The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to placebo in participants with cystic fibrosis (CF) over the 4-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Oral tablet
Oral tablet
USA001
Gainesville, Florida, United States
USA016
Augusta, Georgia, United States
USA025
Glenview, Illinois, United States
Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1
Cmax of Brensocatib on Day 28
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28
Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1
Tmax of Brensocatib on Day 28
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28
Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1
AUC0-24 of Brensocatib in Plasma on Day 28
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28
Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28
Time frame: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
A TEAE is defined as any adverse event (AE) that occurred after the first dose of study investigational medicinal product (IMP) and within 28 days after the last dose of study IMP.
Time frame: Up to Day 56
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28
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USA011
Boston, Massachusetts, United States
USA023
Ann Arbor, Michigan, United States
USA002
St Louis, Missouri, United States
USA022
New York, New York, United States
USA008
Cleveland, Ohio, United States
USA006
Cleveland, Ohio, United States
USA018
Portland, Oregon, United States
...and 4 more locations
Analysis of dose dependency for brensocatib Cmax was performed using a power law model. The logarithm of the Cmax was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship.
Time frame: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28
Analysis of dose dependency for brensocatib AUC0-24 was performed using a power law model. The logarithm of the AUC0-24 was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship.
Time frame: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose
AUClast of Brensocatib in Plasma on Days 1 and 28
Time frame: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUClast, After Administration of Brensocatib on Days 1 and 28
Analysis of dose dependency for brensocatib AUClast was performed using a power law model. The logarithm of the AUClast was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship.
Time frame: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose