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

NCT05965570 | Completed Phase 1 FDA Drug

• 1 other identifier: INS1007-109
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (1)

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

  Up to Day 27

Study Arms (1)

Brensocatib + Clarithromycin

EXPERIMENTAL

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; Drug: Clarithromycin

Interventions

Brensocatib DRUG

Oral tablets.

Also known as: INS1007

Brensocatib + Clarithromycin

Clarithromycin DRUG

Oral tablets.

Brensocatib + Clarithromycin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (1)

USA001

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

brensocatib; Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: July 28, 2023
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)