The study has 2 Parts: The primary purpose of Part 1 is to determine the supratherapeutic dose of brensocatib to be used in Part 2 of the study. The primary purpose of Part 2 is to assess brensocatib's potential for prolonging the QT interval.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
USA001
Madison, Wisconsin, United States
Part 1: Number of Participants who Experienced at least one Treatment-Emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to Day 7
Part 2: Placebo- and Baseline-Corrected QTcF (ΔΔQTcF)
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Brensocatib
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 1 and 2: Time to Maximum Observed Plasma Concentration (Tmax) of Brensocatib
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUCtlast) of Brensocatib
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 1 and 2: AUC From Time Zero Extrapolated to Infinity (AUC∞) of Brensocatib
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 1 and 2: Elimination Half-Life (t1/2) of Brensocatib
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
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Parts 1 and 2: Total Clearance of Brensocatib Following Extravascular Administration (CL/F)
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 1 and 2: Volume of Distribution of Brensocatib Following Extravascular Administration (Vz/F)
Time frame: Part 1: Pre-dose and at multiple timepoints post-dose on Days 1 to 4; Part 2: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Parts 2: Change From Baseline in QTcF (ΔQTcF) Interval
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Part 2: Number of Participants With Categorical Outliers for ECG Parameters: HR, PR, QRS, and QTcF
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 4 in each period
Part 2: Number of Participants who Experienced at least one TEAE
Time frame: 7 days after the last dose (up to 35 days)