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OpenTrials
Completed

NCT Number: NCT05965570

A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants

The primary purpose of this study is to determine the effect of clarithromycin on the single-dose pharmacokinetics (PK) of brensocatib in healthy participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USA001

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females of nonchildbearing potential and males, of any race, between 18 and 65 years of age, inclusive, without current disease.
  • Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg).

Exclusion criteria

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
  • 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 serology test results for hepatitis B panel or hepatitis C antibody and/or reactive human immunodeficiency virus 1/2 test.
  • Participants whose results are compatible with prior immunization for hepatitis B or natural immunity may be included at the discretion of the investigator.
  • Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or check-in.
  • Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.

Treatment and study plan

Brensocatib

Drug

Oral tablets.

Other names: INS1007

Clarithromycin

Drug

Oral tablets.

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20

    The effect of clarithromycin on the single dose pharmacokinetics of brensocatib will be assessed in healthy participants.

Secondary outcomes

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

    Time frame: Up to Day 27

    Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2023
Registry last updated
Dec 11, 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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