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A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT02023125
Recruitment Status : Completed
First Posted : December 30, 2013
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteer
Interventions Drug: Alectinib
Drug: Esomeprazole
Other: High Fat and Calorie Meal
Other: Standard Meal
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Treatment A First, Then Treatment B Group 1: Treatment B First, Then Treatment A Group 2: Alectinib Alone, Alectinib + Esomeprazole
Hide Arm/Group Description Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days. Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Period Title: Period 1
Started 9 9 24
Completed 9 9 24
Not Completed 0 0 0
Period Title: Washout Period
Started 9 9 24
Completed 9 9 24
Not Completed 0 0 0
Period Title: Period 2
Started 9 9 24
Completed 9 9 24
Not Completed 0 0 0
Arm/Group Title Group 1 (Treatment Sequence AB or BA) Group 2: Alectinib Alone, Alectinib + Esomeprazole Total
Hide Arm/Group Description Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence. Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered. Total of all reporting groups
Overall Number of Baseline Participants 18 24 42
Hide Baseline Analysis Population Description
Safety Analysis Set consisted of all participants who received at least 1 dose of study drug and had at least 1 after dosing safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 24 participants 42 participants
35.3  (8.50) 35.4  (8.30) 35.4  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 24 participants 42 participants
Female
1
   5.6%
2
   8.3%
3
   7.1%
Male
17
  94.4%
22
  91.7%
39
  92.9%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Alectinib: Group 1
Hide Description [Not Specified]
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Population [Group 1] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
103  (41.1) 270  (86.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Treatment A (Fasted Treatment), Group 1: Treatment B (Fed Treatment)
Comments Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 270
Confidence Interval (2-Sided) 90%
228 to 320
Estimation Comments The reported values are percentages of geometric least square mean ratio.
2.Primary Outcome
Title Cmax of Alectinib: Group 2
Hide Description [Not Specified]
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
169  (47.3) 196  (54.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Period 1 (Alectinib Alone), Group 2: Period 2 (Alectinib + Esomeprazole)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 116
Confidence Interval (2-Sided) 90%
103 to 132
Estimation Comments The reported values are percentages of geometric least square mean ratio.
3.Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Alectinib: Group 1
Hide Description AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: hours*nanograms per milliliter (h*ng/mL)
1900  (665) 5480  (1800)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Treatment A (Fasted Treatment), Group 1: Treatment B (Fed Treatment)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 292
Confidence Interval (2-Sided) 90%
258 to 329
Estimation Comments The reported values are percentages of geometric least square mean ratio.
4.Primary Outcome
Title AUC0-inf of Alectinib: Group 2
Hide Description AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
3180  (876) 3940  (1310)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Period 1 (Alectinib Alone), Group 2: Period 2 (Alectinib + Esomeprazole)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 122
Confidence Interval (2-Sided) 90%
109 to 136
Estimation Comments The reported values are percentages of geometric least square mean ratio.
5.Secondary Outcome
Title Cmax of RO5468924: Group 1
Hide Description RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ng/mL
37.5  (20.7) 126  (31.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Treatment A (Fasted Treatment), Group 1: Treatment B (Fed Treatment)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 377
Confidence Interval (2-Sided) 90%
303 to 468
Estimation Comments The reported values are percentages of geometric least square mean ratio.
6.Secondary Outcome
Title Cmax of RO5468924: Group 2
Hide Description RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
72.1  (28.8) 72.1  (26.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Period 1 (Alectinib Alone), Group 2: Period 2 (Alectinib + Esomeprazole)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 102
Confidence Interval (2-Sided) 90%
87.0 to 119
Estimation Comments The reported values are percentages of geometric least square mean ratio.
7.Secondary Outcome
Title AUC0-inf of RO5468924: Group 1
Hide Description AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1140  (497) 3480  (758)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Treatment A (Fasted Treatment), Group 1: Treatment B (Fed Treatment)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 328
Confidence Interval (2-Sided) 90%
276 to 389
Estimation Comments The reported values are percentages of geometric least square mean ratio.
8.Secondary Outcome
Title AUC0-inf of RO5468924: Group 2
Hide Description AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1860  (639) 2050  (713)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Period 1 (Alectinib Alone), Group 2: Period 2 (Alectinib + Esomeprazole)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 110
Confidence Interval (2-Sided) 90%
96.3 to 126
Estimation Comments The reported values are percentages of geometric least square mean ratio.
9.Secondary Outcome
Title Metabolite/Parent Ratio for AUC0-inf: Group 1
Hide Description AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
0.610  (0.07) 0.686  (0.08)
10.Secondary Outcome
Title Metabolite/Parent Ratio for AUC0-inf: Group 2
Hide Description AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
0.548  (0.05) 0.607  (0.08)
11.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Group 1
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1780  (648) 5360  (1750)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Treatment A (Fasted Treatment), Group 1: Treatment B (Fed Treatment)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 306
Confidence Interval (2-Sided) 90%
269 to 348
Estimation Comments The reported values are percentages of geometric least square mean ratio.
12.Secondary Outcome
Title AUClast of Alectinib: Group 2
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
3050  (867) 3790  (1280)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Period 1 (Alectinib Alone), Group 2: Period 2 (Alectinib + Esomeprazole)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 122
Confidence Interval (2-Sided) 90%
110 to 136
Estimation Comments The reported values are percentages of geometric least square mean ratio.
13.Secondary Outcome
Title AUClast of RO5468924: Group 1
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1030  (491) 3290  (715)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Treatment A (Fasted Treatment), Group 1: Treatment B (Fed Treatment)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 349
Confidence Interval (2-Sided) 90%
288 to 422
Estimation Comments The reported values are percentages of geometric least square mean ratio.
14.Secondary Outcome
Title AUClast of RO5468924: Group 2
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1750  (617) 1920  (685)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Period 1 (Alectinib Alone), Group 2: Period 2 (Alectinib + Esomeprazole)
Comments ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 109
Confidence Interval (2-Sided) 90%
95.3 to 126
Estimation Comments The reported values are percentages of geometric least square mean ratio.
15.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Group 1
Hide Description [Not Specified]
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
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PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
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Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Median (Full Range)
Unit of Measure: hours
4.00
(2.00 to 8.00)
8.00
(6.00 to 12.0)
16.Secondary Outcome
Title Tmax of Alectinib: Group 2
Hide Description [Not Specified]
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
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PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
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Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Median (Full Range)
Unit of Measure: hours
6.00
(4.00 to 10.0)
6.00
(4.00 to 10.0)
17.Secondary Outcome
Title Tmax of RO5468924: Group 1
Hide Description RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
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PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Median (Full Range)
Unit of Measure: hours
8.00
(4.02 to 12.0)
10.0
(6.00 to 12.0)
18.Secondary Outcome
Title Tmax of RO5468924: Group 2
Hide Description RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
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PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
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Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Median (Full Range)
Unit of Measure: hours
6.02
(6.00 to 12.0)
8.00
(6.00 to 12.0)
19.Secondary Outcome
Title Terminal Half-life (t1/2) of Alectinib: Group 1
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
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PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: hours
23.4  (13.7) 17.7  (5.12)
20.Secondary Outcome
Title t1/2 of Alectinib: Group 2
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
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PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: hours
20.4  (9.33) 20.4  (7.56)
21.Secondary Outcome
Title t1/2 of RO5468924: Group 1
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period
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Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: hours
29.4  (7.05) 22.7  (3.27)
22.Secondary Outcome
Title t1/2 of RO5468924: Group 2
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
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Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Day 16): Participants started the standardized meal 30 minutes prior to administration of alectinib. Participants were to consume this meal in 30 minutes or less. A single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 2 (Days 11 to 20): From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40-mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: hours
25.0  (4.56) 25.4  (5.06)
23.Secondary Outcome
Title Apparent Oral Clearance (CL/F) for Alectinib: Group 1
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
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Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: Liters per hour (L/h)
357  (136) 120  (38.1)
24.Secondary Outcome
Title CL/F for Alectinib: Group 2
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
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Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: L/h
206  (72.5) 170  (61.0)
25.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) for Alectinib: Group 1
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
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Hide Analysis Population Description
PK Analysis Population [Group 1]
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment)
Hide Arm/Group Description:
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: Liters
11800  (7200) 3060  (1290)
26.Secondary Outcome
Title Vz/F for Alectinib: Group 2
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.
Time Frame Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period
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Hide Analysis Population Description
PK Analysis Population [Group 2]
Arm/Group Title Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description:
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: Liters
5930  (2950) 4890  (2070)
Time Frame Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Adverse Event Reporting Description Safety Analysis Set.
 
Arm/Group Title Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment) Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Esomeprazole Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Hide Arm/Group Description Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
All-Cause Mortality
Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment) Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Esomeprazole Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment) Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Esomeprazole Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: Treatment A (Fasted Treatment) Group 1: Treatment B (Fed Treatment) Group 2: Period 1 (Alectinib Alone) Group 2: Period 2 (Esomeprazole Alone) Group 2: Period 2 (Alectinib + Esomeprazole)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/18 (44.44%)   8/18 (44.44%)   5/24 (20.83%)   3/24 (12.50%)   4/24 (16.67%) 
Ear and labyrinth disorders           
Ear pain * 1  1/18 (5.56%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Eye disorders           
Conjunctival hyperaemia * 1  0/18 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders           
Constipation * 1  1/18 (5.56%)  1/18 (5.56%)  2/24 (8.33%)  0/24 (0.00%)  1/24 (4.17%) 
Lip dry * 1  2/18 (11.11%)  2/18 (11.11%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Nausea * 1  1/18 (5.56%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Vomiting * 1  1/18 (5.56%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Dry mouth * 1  0/18 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Dyspepsia * 1  0/18 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Diarrhoea * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%) 
General disorders           
Vessel puncture site pain * 1  0/18 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Influenza-like illness * 1  0/18 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Application site pruritus * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%) 
Infections and infestations           
Nasopharyngitis * 1  1/18 (5.56%)  0/18 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  0/24 (0.00%) 
Injury, poisoning and procedural complications           
Laceration * 1  0/18 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Contusion * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%) 
Excoriation * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders           
Myalgia * 1  1/18 (5.56%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Joint stiffness * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  0/24 (0.00%) 
Nervous system disorders           
Headache * 1  2/18 (11.11%)  1/18 (5.56%)  0/24 (0.00%)  1/24 (4.17%)  0/24 (0.00%) 
Dizziness * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Nasal congestion * 1  1/18 (5.56%)  0/18 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Rhinorrhoea * 1  1/18 (5.56%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Cough * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/24 (0.00%)  1/24 (4.17%) 
Skin and subcutaneous tissue disorders           
Dry skin * 1  1/18 (5.56%)  0/18 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Skin reaction * 1  0/18 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/24 (0.00%)  0/24 (0.00%) 
Rash papular * 1  0/18 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/24 (0.00%)  0/24 (0.00%) 
Pruritus * 1  0/18 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/24 (4.17%)  0/24 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02023125     History of Changes
Other Study ID Numbers: NP28991
First Submitted: December 23, 2013
First Posted: December 30, 2013
Results First Submitted: August 16, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016