The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral tablet.
USA002
Rialto, California, United States
USA003
Orlando, Florida, United States
USA001
San Antonio, Texas, United States
Area Under the Concentration Time Curve (AUC)
Comparison of the pharmacokinetics of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Fraction Unbound (Fu)
Assessment of the plasma protein binding of brensocatib in participants with varying degrees of hepatic function relative to matched healthy control participants with normal hepatic function.
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
Number of Participants who Experienced at Least one Adverse Event (AE)
Determination of the safety and tolerability of a single dose of brensocatib in participants with hepatic impairment.
Time frame: From first dose of study drug up to follow up visit (5-7 days after discharge) or early termination (up to Day 17)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.