Brensocatib
DrugOral tablet.
Other names: INS1007
NCT Number: NCT05517525
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
USA002, Rialto, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for Participants With Hepatic Impairment:
Inclusion criteria
for Healthy Matched Control Participants With Normal Hepatic Function:
Exclusion criteria
Exclusion criteria
for Participants With Hepatic Impairment:
Exclusion criteria
for Healthy Matched Control Participants with Normal Hepatic Function
Oral tablet.
Other names: INS1007
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 9
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
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: From first dose of study drug up to follow up visit (5-7 days after discharge) or early termination (up to Day 17)
Determination of the safety and tolerability of a single dose of brensocatib in participants with hepatic impairment.
Insmed Incorporated
Industry
An Open-label, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Brensocatib in Subjects With Normal Hepatic Function and Subjects With Hepatic Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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