Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant

NCT ID: NCT05959447

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-26
• Study Completion Date: 2023-10-13

Brief Summary

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating potential drug-drug interactions between gemfibrozil (part 1) or dabigatran etexilate (part 2) and camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.

Conditions

Cough; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg

Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5.

Group Type: EXPERIMENTAL

Camlipixant

Intervention Type: DRUG

Camlipixant will be administered

Gemfibrozil

Intervention Type: DRUG

Gemfibrozil will be administered.

Part 2: Dabigatran etexilate 150 mg + camlipixant 50 mg

Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1, followed by repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. There was a washout of at least 4 days between the dose of dabigatran etexilate on Day 1 and the dose of camlipixant on Day 5.

Group Type: EXPERIMENTAL

Camlipixant

Intervention Type: DRUG

Camlipixant will be administered

Dabigatran etexilate

Intervention Type: DRUG

Dabigatran etexilate will be administered

Interventions

Camlipixant

Camlipixant will be administered

Intervention Type: DRUG

Dabigatran etexilate

Dabigatran etexilate will be administered

Intervention Type: DRUG

Gemfibrozil

Gemfibrozil will be administered.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria

• History of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disorder, as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bellus Health Inc. - a GSK company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Québec, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BUS-P1-12

Identifier Type: OTHER

Identifier Source: secondary_id

221854

Identifier Type: -

Identifier Source: org_study_id