Hepatic Impairment
Conditions
Keywords
Brensocatib, INS1007
Brief summary
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.
Interventions
DRUGBrensocatib
Oral tablet.
Sponsors
Insmed Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
\- Has body mass index (BMI) between 18.0 and 35.0 kilogram per square meter (kg/m\^2) Inclusion Criteria for Participants With Hepatic Impairment: * Clinical diagnosis of chronic hepatic disease, as documented in their medical history of underlying hepatic insufficiency with features of cirrhosis and no acute episodes of illness within 30 days prior to screening, and no significant change in disease status from screening to check-in. * Hepatic impairment will be classified using the Child-Pugh criteria * A stable medication regimen, defined as not starting new drug(s) or changing dosage(s) within 30 days prior to study drug administration. Concomitant medications must be approved by the investigator and medical monitor. Inclusion Criteria for Healthy Matched Control Participants With Normal Hepatic Function: * In good health, determined by no clinically significant findings from medical history, clinical laboratory evaluations, vital signs measurements, 12-lead electrocardiogram (ECG), and physical examination at screening or check-in, as assessed by the investigator (or designee). * Matched to hepatically impaired participants in age (±10 years), sex, and BMI (±20%).
Exclusion criteria
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed). * Positive human immunodeficiency virus (HIV) test * Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 30 days prior to dosing. * Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing. * Use of moderate to strong CYP3A4 inducers or inhibitors within 14 days prior to check-in. * Have previously completed or withdrawn from this study or any other study investigating brensocatib, and have previously received the IMP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction Unbound (Fu) | 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. |
| Number of Participants who Experienced at Least one Adverse Event (AE) | 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. |
Countries
United States
Outcome results
None listed