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Trial record 21 of 39 for:    ALECTINIB

A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802

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ClinicalTrials.gov Identifier: NCT01940510
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : October 18, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Healthy Volunteer
Interventions Drug: RO5424802
Drug: rifampin
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Whole Study: Alectinib + Rifampin
Hide Arm/Group Description There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules [two 300 mg capsules] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Whole Study: Alectinib + Rifampin
Hide Arm/Group Description There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least one dose of the study treatment and had at least 1 postdose safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
35.3  (9.43)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
2
   8.3%
Male
22
  91.7%
1.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib
Hide Description AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis set included all participants who received both scheduled doses of alectinib (on Day 1 and Day 17), and provided adequate PK assessments.
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*hour/mL
3990  (1550) 1020  (240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 1: Alectinib, Treatment Period 3: Alectinib + Rifampin
Comments Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 26.8
Confidence Interval (2-Sided) 90%
23.8 to 30.1
Estimation Comments The reported values are percentages of geometric least square mean ratio.
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Alectinib
Hide Description Cmax is the maximum observed alectinib plasma concentration, presented in nanogram per milliliter (ng/mL).
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
212  (78.3) 101  (30.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 1: Alectinib, Treatment Period 3: Alectinib + Rifampin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 48.6
Confidence Interval (2-Sided) 90%
43.5 to 54.3
Estimation Comments ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.
3.Secondary Outcome
Title AUC(0-inf) of RO5468924
Hide Description AUC(0-inf) is the area under the RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the drug over time. AUC(0-inf) is presented in ng*hour/mL.
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*hour/mL
2250  (904) 3970  (1600)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 1: Alectinib, Treatment Period 3: Alectinib + Rifampin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 179
Confidence Interval (2-Sided) 90%
158 to 202
Estimation Comments ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.
4.Secondary Outcome
Title Cmax of RO5468924
Hide Description Cmax is the maximum observed RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration, presented in ng/mL.
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
90.5  (43.7) 194  (97.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Period 1: Alectinib, Treatment Period 3: Alectinib + Rifampin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Least Square Mean Ratio
Estimated Value 220
Confidence Interval (2-Sided) 90%
190 to 255
Estimation Comments ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.
5.Secondary Outcome
Title Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)
Hide Description AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
0.59  (0.05) 3.96  (0.67)
6.Secondary Outcome
Title Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
0.42  (0.07) 1.92  (0.32)
7.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924
Hide Description AUC(0-last) is the area under the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) plasma concentration time-curve from time zero to the last measured concentration. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng*hour/mL
Alectinib 3860  (1500) 976  (234)
RO5468924 2140  (876) 3850  (1570)
8.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924
Hide Description The Tmax is the time from alectinib administration to reach Cmax for alectinib and RO5468924 (the major pharmacologically active metabolite of alectinib).
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Median (Full Range)
Unit of Measure: hours
Alectinib
6.00
(4.00 to 12.00)
4.00
(4.00 to 8.00)
RO5468924
8.00
(6.00 to 12.00)
6.00
(6.00 to 8.00)
9.Secondary Outcome
Title Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924
Hide Description Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: hours
Alectinib 19.2  (4.41) 11.0  (5.65)
RO5468924 24.0  (3.48) 23.0  (11.1)
10.Secondary Outcome
Title Apparent Oral Clearance (CL/F) of Alectinib
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 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: liters/hour
179  (89.1) 627  (170)
11.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) of Alectinib
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. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: liters
4710  (1890) 9960  (5880)
12.Secondary Outcome
Title Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)
Hide Description AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the molar plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: nmol*hour/L
13200  (4670) 10800  (3910)
13.Secondary Outcome
Title Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax
Hide Description Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).
Time Frame Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description:
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: nmol/L
614  (231) 594  (251)
Time Frame Day 1 through follow-up (up to 31 days)
Adverse Event Reporting Description Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
 
Arm/Group Title Treatment Period 1: Alectinib Treatment Period 2: Rifampin Treatment Period 3: Alectinib + Rifampin
Hide Arm/Group Description Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1. Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16. Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
All-Cause Mortality
Treatment Period 1: Alectinib Treatment Period 2: Rifampin Treatment Period 3: Alectinib + Rifampin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period 1: Alectinib Treatment Period 2: Rifampin Treatment Period 3: Alectinib + Rifampin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   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 5%
Treatment Period 1: Alectinib Treatment Period 2: Rifampin Treatment Period 3: Alectinib + Rifampin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/24 (4.17%)   16/24 (66.67%)   1/24 (4.17%) 
Gastrointestinal disorders       
Faeces discoloured * 1  0/24 (0.00%)  2/24 (8.33%)  0/24 (0.00%) 
Infrequent bowel movements * 1  0/24 (0.00%)  2/24 (8.33%)  0/24 (0.00%) 
Nervous system disorders       
Headache * 1  1/24 (4.17%)  2/24 (8.33%)  0/24 (0.00%) 
Renal and urinary disorders       
Chromaturia * 1  0/24 (0.00%)  14/24 (58.33%)  1/24 (4.17%) 
*
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
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01940510     History of Changes
Other Study ID Numbers: NP29042
First Submitted: September 9, 2013
First Posted: September 12, 2013
Results First Submitted: August 25, 2016
Results First Posted: October 18, 2016
Last Update Posted: December 21, 2016