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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05965570
• Other study ID #: INS1007-109
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2023
• Est. completion date: September 22, 2023

Study information

• Verified date: December 2023
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Brensocatib
Oral tablets.
• Clarithromycin
Oral tablets.

Locations

Country	Name	City	State
United States	USA001	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants who Experienced at Least one Adverse Event (AE)	Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants.	Up to Day 27