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

• ClinicalTrials.gov Identifier: NCT05965570
• Recruitment Status: Completed
• First Posted: July 28, 2023
• Last Update Posted: December 11, 2023
• Sponsor: Insmed Incorporated
• Information provided by (Responsible Party): Insmed Incorporated

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
Healthy Volunteers	Drug: Brensocatib; Drug: Clarithromycin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: July 28, 2023
• Actual Primary Completion Date: September 22, 2023
• Actual Study Completion Date: September 22, 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 Name: INS1007; Drug: Clarithromycin; Oral tablets.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, Texas

USA001

Dallas, Texas, United States, 75247

Sponsors and Collaborators

Insmed Incorporated

More Information

• Responsible Party: Insmed Incorporated
• ClinicalTrials.gov Identifier: NCT05965570
• Other Study ID Numbers: INS1007-109
• First Posted: July 28, 2023
• Last Update Posted: December 11, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• 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; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors