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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05826574
• Other study ID #: INS1007-106
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2023
• Est. completion date: July 16, 2023

Study information

• Verified date: August 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 16, 2023
• Est. primary completion date: July 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Brensocatib
Oral tablets.
• Rifampin
Oral capsules.
• Esomeprazole
Oral capsules.

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	Parts 1 and 2: Area Under the Concentration-time (AUC) of Brensocatib in Plasma	Pharmacokinetics of brensocatib following a single dose in healthy participants will be assessed.	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)
Secondary	Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event (AE)	Safety and tolerability of brensocatib when administered alone and in combination with rifampin/esomeprazole will be determined in healthy participants.	Up to Day 31 (Part 1) and up to Day 26 (Part 2)