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Completed

NCT Number: NCT05517525

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

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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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA002, Rialto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

for Participants With Hepatic Impairment:

  • 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.

Exclusion criteria

for Healthy Matched Control Participants with Normal Hepatic Function

  • 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.

Treatment and study plan

Brensocatib

Drug

Oral tablet.

Other names: INS1007

Primary outcomes

  1. Area Under the Concentration Time Curve (AUC)

    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.

Secondary outcomes

  1. Fraction Unbound (Fu)

    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.

  2. Number of Participants who Experienced at Least one Adverse Event (AE)

    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.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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