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

Bellus Health

Status and phase: Completed; Phase 1

Conditions: Healthy; Cough

Treatments: Drug: Gemfibrozil; Drug: Dabigatran etexilate; Drug: Camlipixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05959447

221854

BUS-P1-12

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg

Experimental group

Description:

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.

Treatment:

Drug: Camlipixant

Drug: Gemfibrozil

Part 2: Dabigatran etexilate 150 mg + camlipixant 50 mg

Experimental group

Description:

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.

Treatment:

Drug: Camlipixant

Drug: Dabigatran etexilate