Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant

Bellus Health

Status and phase: Completed; Phase 1

Conditions: Healthy; Cough

Treatments: Drug: Rifampin; Drug: Rabeprazole; Drug: Camlipixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05899829

BUS-P1-11

221853

Details and patient eligibility

About

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.

Enrollment: 42 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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42 participants in 2 patient groups

Part 1: Camlipixant 50 mg + Rifampin 600 mg

Experimental group

Description:

Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4.

Treatment:

Drug: Camlipixant

Drug: Rifampin

Part 2: Camlipixant 50 mg + Rabeprazole 20 mg

Experimental group

Description:

Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4

Treatment:

Drug: Camlipixant

Drug: Rabeprazole