A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

NCT ID: NCT05517525

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2023-06-01

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Brensocatib

Healthy participants with normal hepatic function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with hepatic impairment.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet.

Cohort 2: Brensocatib

Participants with mild hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet.

Cohort 3: Brensocatib

Participants with moderate hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet.

Cohort 4: Brensocatib

Participants with severe hepatic impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.

Group Type: EXPERIMENTAL

Brensocatib

Intervention Type: DRUG

Oral tablet.

Interventions

Brensocatib

Oral tablet.

Intervention Type: DRUG

Other Intervention Names

INS1007

Eligibility Criteria

Inclusion Criteria

• Has body mass index (BMI) between 18.0 and 35.0 kilogram per square meter (kg/m^2)

• 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.

• 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.

• Positive urine drug screen at screening or check-in, unless the result is due to a prescribed medication.
• History of significant immunologic impairment such as transplantation.
• Hepatic encephalopathy Grade ≥2 using Child-Pugh scoring.

• Positive urine drug screen at screening or check-in.
• Significant history or clinical manifestation of any immunologic, metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• Positive hepatitis panel. Participants whose results are compatible with prior immunization are eligible at the discretion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insmed Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USA002

Rialto, California, United States

USA003

Orlando, Florida, United States

USA001

San Antonio, Texas, United States

Countries

United States

Other Identifiers

INS1007-105

Identifier Type: -

Identifier Source: org_study_id