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A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants

Sponsor
Insmed Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05826574
Collaborator
(none)
32
Enrollment
4
Arms
2.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary purpose of this study is to assess the effects of rifampin on the PK of brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of brensocatib in Part 2 of the study.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open Label, Fixed Sequence Study to Assess the Pharmacokinetics of Brensocatib When Administered Alone and With Multiple Doses of Rifampin (CYP3A Inducer) or Esomeprazole (Proton Pump Inhibitor) in Healthy Subjects
Anticipated Study Start Date :
Apr 21, 2023
Anticipated Primary Completion Date :
Jul 17, 2023
Anticipated Study Completion Date :
Jul 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Period 1: Brensocatib

Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 1 of the study.

Drug: Brensocatib
Oral tablets.
Other Names:
  • INS1007

    		•
    Experimental: Part 1: Period 2: Brensocatib + Rifampin

    Period 2: Participants will receive rifampin 600 mg once daily (QD), orally, on Days 8 to 23 along with a single oral dose of brensocatib prior to the rifampin administration on Day 17 in Part 1 of the study.

    Drug: Brensocatib
    Oral tablets.
    Other Names:
  • INS1007

    • Drug: Rifampin
    Oral capsules.
    Experimental: Part 2: Period 1: Brensocatib

    Period 1: Participants will receive a single oral dose of brensocatib on Day 1 in Part 2 of the study.

    Drug: Brensocatib
    Oral tablets.
    Other Names:
  • INS1007

    		•
    Experimental: Part 2: Period 2: Brensocatib + Esomeprazole

    Period 2: Participants will receive esomeprazole 40 mg QD, orally, on Days 8 to 12 along with a single oral dose of brensocatib prior to the esomeprazole administration on Day 12 in Part 2 of the study.

    Drug: Brensocatib
    Oral tablets.
    Other Names:
  • INS1007

    • Drug: Esomeprazole
    Oral capsules.

    Outcome Measures

    Primary Outcome Measures

    1. Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma [Pre-dose and at multiple timepoints post-dose on Days 1 to 7, 17 (Part 1), and Days 1 to 7, 12 to 18 (Part 2)]

      Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.

    Secondary Outcome Measures

    1. Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE) [Up to Day 31 (Part 1) and up to Day 26 (Part 2)]

      Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy participants defined by no significant other conditions as in the protocol.
    Exclusion Criteria:

    • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immunological, oncologic, 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, as determined by the investigator (or designee).

    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:
    NCT05826574
    Other Study ID Numbers:
    • INS1007-106
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Apr 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
    Keywords provided by Insmed Incorporated
    Brensocatib
    INS1007
    Additional relevant MeSH terms:
    Rifampin
    Esomeprazole

    Study Results

    No Results Posted as of Apr 24, 2023