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A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119649
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Drug: GLPG2222 50 mg
Drug: GLPG2222 100 mg
Drug: Placebo
Drug: GLPG2222 200 mg
Drug: GLPG2222 400 mg
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description Participants received three matching placebo tablets orally, once a day (QD) for 29 days. Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days. Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days. Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days. Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet, orally, QD for 29 days.
Period Title: Overall Study
Started 11 10 10 14 14
Completed 11 10 10 14 14
Not Completed 0 0 0 0 0
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD Total
Hide Arm/Group Description Participants received three matching placebo tablets orally, QD for 29 days. Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days. Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days. Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days. Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days. Total of all reporting groups
Overall Number of Baseline Participants 11 10 10 14 14 59
Hide Baseline Analysis Population Description
Safety population: all participants who received at least one dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 10 participants 14 participants 14 participants 59 participants
27.0
(21 to 58)
26.0
(20 to 37)
24.0
(18 to 35)
32.0
(19 to 47)
26.0
(19 to 59)
27.0
(18 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 14 participants 14 participants 59 participants
Female
4
  36.4%
3
  30.0%
6
  60.0%
7
  50.0%
5
  35.7%
25
  42.4%
Male
7
  63.6%
7
  70.0%
4
  40.0%
7
  50.0%
9
  64.3%
34
  57.6%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 14 participants 14 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
11
 100.0%
9
  90.0%
10
 100.0%
13
  92.9%
13
  92.9%
56
  94.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  10.0%
0
   0.0%
1
   7.1%
1
   7.1%
3
   5.1%
[1]
Measure Description: Unknown data were not reported because local regulations did not allow the Sponsor to ask for the information.
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).
Time Frame First administration (Day 1) through Follow-up (Day 43)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received three matching placebo tablets orally, QD for 29 days.
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 11 10 10 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
9
  81.8%
8
  80.0%
10
 100.0%
11
  78.6%
9
  64.3%
Any Serious TEAE
2
  18.2%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
Worst TEAE Intensity=Mild
6
  54.5%
4
  40.0%
7
  70.0%
8
  57.1%
9
  64.3%
Worst TEAE Intensity=Moderate
2
  18.2%
4
  40.0%
2
  20.0%
2
  14.3%
0
   0.0%
Worst TEAE Intensity=Severe
1
   9.1%
0
   0.0%
1
  10.0%
1
   7.1%
0
   0.0%
Any Treatment-related TEAE
2
  18.2%
2
  20.0%
6
  60.0%
5
  35.7%
1
   7.1%
2.Secondary Outcome
Title Mean Change From Baseline in Sweat Chloride Concentration at Day 29
Hide Description Two sweat collections, one from each arm, were obtained. Mean sweat chloride concentration was determined from both arms and measured as millimoles per liter (mmol/L). Baseline was defined as the predose value on Day 1 (or the last non-missing predose measurement).
Time Frame Prior to dosing on Days 1 and 29, or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all enrolled participants who received at least one dose of study drug and had at least one post-baseline assessment with efficacy data. Only participants with non-missing data at baseline were included in the analysis; 3 participants had missing sweat chloride concentration data at baseline.
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received three matching placebo tablets orally, QD for 29 days.
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 11 9 8 14 14
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-2.5  (2.79) -5.8  (3.08) -6.6  (3.29) -18.3  (2.49) -8.8  (2.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort A: GLPG2222 50 mg QD
Comments Day 29: GLPG2222 50 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4291
Comments P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -3.3
Confidence Interval (2-Sided) 95%
-11.6 to 5.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort A: GLPG2222 100 mg QD
Comments Day 29: GLPG2222 100 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3477
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -4.10
Confidence Interval (2-Sided) 95%
-12.8 to 4.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort B: GLPG2222 200 mg QD
Comments Day 29: GLPG2222 200 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -15.8
Confidence Interval (2-Sided) 95%
-23.2 to -8.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort B: GLPG2222 400 mg QD
Comments Day 29: GLPG2222 400 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0995
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -6.3
Confidence Interval (2-Sided) 95%
-13.9 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.76
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline in Percent (%) Predicted FEV1 (%FEV1) at Day 29
Hide Description Percent predicted FEV1 for age, gender, and height was determined from standardized spirometry assessments and estimated using the 2012 Global Lungs Initiative equation. Baseline was defined as the last non-missing predose assessment on Day 1.
Time Frame Predose and between 1 and 2 hours postdose on Days 1 and 29, or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received three matching placebo tablets orally, QD for 29 days.
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 11 10 10 14 14
Least Squares Mean (Standard Error)
Unit of Measure: % predicted FEV1
-1.0  (1.45) 0.1  (1.50) -0.3  (1.51) 0.0  (1.27) 1.3  (1.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort A: GLPG2222 50 mg QD
Comments Day 29: GLPG2222 50 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5940
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-3.1 to 5.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort A: GLPG2222 100 mg QD
Comments Day 29: GLPG2222 100 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7553
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-3.5 to 4.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort B: GLPG2222 200 mg QD
Comments Day 29: GLPG2222 200 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5958
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-2.9 to 4.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort B: GLPG2222 400 mg QD
Comments Day 29: GLPG2222 400 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2403
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-1.6 to 6.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.94
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at Day 29
Hide Description The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. The respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), derived from Questions 40, 41, 42, 45, and 46 if at least 50% of the questions had non-missing data. The scale score ranged from 0-100; higher scores indicated fewer symptoms and better health-related quality of life with a negative change indicating a worsening of symptoms. A change of 4 is considered clinically relevant.
Time Frame Prior to dosing on Days 1 and 29, or at early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received three matching placebo tablets orally, QD for 29 days.
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 11 10 10 14 14
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.4  (3.32) 0.4  (3.47) -0.7  (3.48) 4.5  (2.93) -0.8  (2.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort A: GLPG2222 50 mg QD
Comments Day 29: GLPG2222 50 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5749
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.9 to 12.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort A: GLPG2222 100 mg QD
Comments Day 29: GLPG2222 100 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7381
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-8.1 to 11.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort B: GLPG2222 200 mg QD
Comments Day 29: GLPG2222 200 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1282
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
-2.0 to 15.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pooled Placebo, Cohort B: GLPG2222 400 mg QD
Comments Day 29: GLPG2222 400 mg QD vs. Pooled Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7212
Comments P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-7.3 to 10.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.43
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Maximum Observed Plasma Concentration (Cmax; Nanograms Per Milliliter [mg/mL]) of GLPG2222
Hide Description Maximum concentration of GLPG2222 after multiple dosing (ng/ML), obtained directly from the observed concentration versus time data. All pharmacokinetic (PK) parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
Time Frame Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants who were exposed to GLPG2222 and who had available and evaluable PK data (excluding all protocol violations/deviations or adverse events that may have had an impact on the PK analysis). Data were not calculable for 1 patient.
Arm/Group Title Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 10 10 14 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
478  (128) 1170  (395) 2490  (535) 5330  (2700)
6.Secondary Outcome
Title Mean GLPG2222 Plasma Concentration Observed at Predose (Ctrough; ng/mL)
Hide Description Plasma concentration of GLPG2222 observed at pre-dose (ng/mL), obtained directly from the observed concentration versus time data. Ctrough was calculated using both Day 15 and Day 29 PK data.
Time Frame Days 15 and 29 (predose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 10 10 14 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
48.1  (33.7) 132  (87.2) 343  (204) 677  (659)
7.Secondary Outcome
Title Median Time to Occurrence of GLPG2222 Cmax (Tmax; Hours [h])
Hide Description Time of occurrence of maximum concentration of GLPG2222 after multiple dosing (h), obtained directly from the observed concentration versus time data. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
Time Frame Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population; data were not calculable for 1 patient.
Arm/Group Title Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 10 10 14 13
Median (Full Range)
Unit of Measure: hours
2.0
(1.0 to 6.0)
2.0
(2.0 to 6.0)
3.0
(2.0 to 4.0)
2.0
(0.5 to 6.0)
8.Secondary Outcome
Title Mean Area Under the Concentration-Time Curve From Time 0 up to 24 Hours Following Multiple Dosing (AUC[0-t]; ng.h/mL) of GLPG2222
Hide Description Area under the concentration-time curve from time 0 up to 24 hours following multiple dosing (ng.h/mL), calculated by linear up/log down trapezoidal summation. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.
Time Frame Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population; data were not calculable for 1 patient.
Arm/Group Title Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description:
Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days.
Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days.
Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
Overall Number of Participants Analyzed 10 10 14 13
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
3850  (1670) 9670  (3770) 22900  (7530) 46400  (25500)
Time Frame From signing of Informed Consent Form (ICF; Screening, Day -28) until the final follow-up visit (Day 43)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Hide Arm/Group Description Participants received three matching placebo tablets orally, QD for 29 days. Participants received a single GLPG2222 50 mg tablet and two matching placebo tablets, orally, QD for 29 days. Participants received a single GLPG2222 100 mg tablet and two matching placebo tablets, orally, QD for 29 days. Participants received two GLPG2222 100 mg tablets and one matching placebo tablet, orally, QD for 29 days. Participants received two GLPG2222 150 mg tablets and one GLPG2222 100 mg tablet orally, QD for 29 days.
All-Cause Mortality
Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Hide Serious Adverse Events
Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/11 (18.18%)   0/10 (0.00%)   1/10 (10.00%)   0/14 (0.00%)   0/14 (0.00%) 
Infections and infestations           
Infective pulmonary exacerbation of cystic fibrosis  1  2/11 (18.18%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pooled Placebo Cohort A: GLPG2222 50 mg QD Cohort A: GLPG2222 100 mg QD Cohort B: GLPG2222 200 mg QD Cohort B: GLPG2222 400 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/11 (81.82%)   8/10 (80.00%)   10/10 (100.00%)   11/14 (78.57%)   9/14 (64.29%) 
Blood and lymphatic system disorders           
Anaemia  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Eye disorders           
Blepharospasm  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Eye pruritus  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  0/11 (0.00%)  0/10 (0.00%)  3/10 (30.00%)  1/14 (7.14%)  1/14 (7.14%) 
Abdominal pain  1  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Abdominal pain upper  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/14 (7.14%)  2/14 (14.29%) 
Nausea  1  0/11 (0.00%)  1/10 (10.00%)  2/10 (20.00%)  0/14 (0.00%)  0/14 (0.00%) 
Dyspepsia  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Constipation  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Gastrointestinal motility disorder  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Gastrointestinal pain  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Gastrooesophageal reflux disease  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Tongue discolouration  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Toothache  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Vomiting  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
General disorders           
Fatigue  1  1/11 (9.09%)  1/10 (10.00%)  2/10 (20.00%)  1/14 (7.14%)  2/14 (14.29%) 
Pyrexia  1  0/11 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  2/14 (14.29%)  0/14 (0.00%) 
Adverse drug reaction  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Asthenia  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  1/14 (7.14%)  0/14 (0.00%) 
Chest discomfort  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  1/14 (7.14%) 
Catheter site related reaction  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Exercise tolerance increased  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Pain  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Infections and infestations           
Infective pulmonary exacerbation of cystic fibrosis  1  1/11 (9.09%)  2/10 (20.00%)  1/10 (10.00%)  2/14 (14.29%)  2/14 (14.29%) 
Viral upper respiratory tract infection  1  1/11 (9.09%)  1/10 (10.00%)  1/10 (10.00%)  3/14 (21.43%)  1/14 (7.14%) 
Ear infection  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Enterovirus infection  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Gastrointestinal infection  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Pharyngitis  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Pseudomonas infection  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Purulent discharge  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Respiratory tract infection viral  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Sinusitis  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Skin candida  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Tooth abscess  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Tooth infection  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Urinary tract infection  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Injury, poisoning and procedural complications           
Wound  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Investigations           
Blood alkaline phosphatase increased  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Blood glucose decreased  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Blood uric acid increased  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Body temperature increased  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Hepatic enzyme increased  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Lymphocyte count decreased  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Neutrophil count increased  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Platelet count increased  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Red blood cells urine positive  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Thrombin time prolonged  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Urine leukocyte esterase positive  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Weight decreased  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
White blood cell count increased  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
White blood cells urine positive  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Diabetes mellitus inadequate control  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Arthralgia  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Arthritis  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Neck pain  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Nervous system disorders           
Headache  1  1/11 (9.09%)  3/10 (30.00%)  3/10 (30.00%)  5/14 (35.71%)  3/14 (21.43%) 
Dizziness  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Lethargy  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Loss of consciousness  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Memory impairment  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Retrograde amnesia  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Psychiatric disorders           
Insomnia  1  1/11 (9.09%)  0/10 (0.00%)  1/10 (10.00%)  1/14 (7.14%)  0/14 (0.00%) 
Renal and urinary disorders           
Leukocyturia  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Renal colic  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Reproductive system and breast disorders           
Azoospermia  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Menstruation irregular  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  3/11 (27.27%)  5/10 (50.00%)  0/10 (0.00%)  3/14 (21.43%)  4/14 (28.57%) 
Sputum increased  1  1/11 (9.09%)  5/10 (50.00%)  1/10 (10.00%)  1/14 (7.14%)  1/14 (7.14%) 
Dyspnoea  1  1/11 (9.09%)  2/10 (20.00%)  1/10 (10.00%)  1/14 (7.14%)  0/14 (0.00%) 
Epistaxis  1  1/11 (9.09%)  1/10 (10.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Haemoptysis  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  1/14 (7.14%)  1/14 (7.14%) 
Nasal Congestion  1  1/11 (9.09%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  1/14 (7.14%) 
Oropharyngeal pain  1  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Upper-airway cough syndrome  1  1/11 (9.09%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Decreased bronchial secretion  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Dysphonia  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Pleuritic pain  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Pulmonary congestion  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Pulmonary haemorrhage  1  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Respiratory depth decreased  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Respiratory tract congestion  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Sputum decreased  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
Sputum discoloured  1  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders           
Rash  1  0/11 (0.00%)  0/10 (0.00%)  2/10 (20.00%)  0/14 (0.00%)  0/14 (0.00%) 
Pruritus  1  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/14 (0.00%)  0/14 (0.00%) 
Surgical and medical procedures           
Tooth extraction  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/14 (7.14%)  0/14 (0.00%) 
Vascular disorders           
Hot flush  1  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/14 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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 investigator must agree that before publishing or communicating any results of the trial, the sponsor has at least 90 days for full review of the information prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Evelyn Fox
Organization: Galapagos NV
Phone: 0032 15 34 29 00
EMail: evelyn.fox@glpg.com
Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03119649    
Other Study ID Numbers: GLPG2222-CL-202
First Submitted: April 11, 2017
First Posted: April 18, 2017
Results First Submitted: October 19, 2018
Results First Posted: November 16, 2018
Last Update Posted: November 16, 2018