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

Sponsor
Insmed Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965570
Collaborator
(none)
22
Enrollment
1
Arm
1.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Jul 24, 2023
Anticipated Primary Completion Date :
Sep 14, 2023
Anticipated Study Completion Date :
Sep 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brensocatib + Clarithromycin

Participants will receive a single oral dose of brensocatib in the morning on Days 1 and 13 after an overnight fast, and oral doses of clarithromycin, twice daily (BID), with food on Days 8 to 19. On Day 13, brensocatib will be coadministered with the morning dose of clarithromycin. Clarithromycin can be taken with food, with the exception of the morning dose on the day of coadministration with brensocatib (Day 13), which will be taken after an overnight fast.

Drug: Brensocatib
Oral tablets.
Other Names:
  • INS1007

    • Drug: Clarithromycin
    Oral tablets.

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Insmed Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Insmed Incorporated
    ClinicalTrials.gov Identifier:
    NCT05965570
    Other Study ID Numbers:
    • INS1007-109
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Clarithromycin

    Study Results

    No Results Posted as of Jul 28, 2023