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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Camlipixant + Rifampin; Drug: Camlipixant + Rabeprazole

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Denis Garceau, Ph.D.; Phone Number: 1-888-540-5867; Email: clinicaltrials@bellushealth.com

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1P 0A2
      • Syneos Health
      • Contact: Bruno Francoeur, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rifampin effect on camlipixant pharmacokinetics	Drug: Camlipixant + Rifampin; Camlipixant will be administered alone as well as in co-administration with rifampin
Experimental: Rabeprazole effect on camlipixant pharmacokinetics	Drug: Camlipixant + Rabeprazole; Camlipixant will be administered alone as well as in co-administration with rabeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the area under the plasma concentration by time curve (AUC0-inf)	To assess the comparison between AUC0-inf following administration of camlipixant alone and after repeated oral doses of rifampin	Pre dose to up to 48 hours post-dose
Measurement of the area under the plasma concentration by time curve (AUC0-t)	To assess the comparison between AUC0-t following administration of camlipixant alone and after repeated oral doses of rifampin	Pre dose to up to 48 hours post-dose
Measurement of the maximum observed plasma drug concentration (Cmax)	To assess the comparison between Cmax following administration of camlipixant alone and after repeated oral doses of rifampin	Pre dose to up to 48 hours post-dose
Measurement of the area under the plasma concentration by time curve (AUC0-inf)	To assess the comparison between AUC0-inf following administration of camlipixant alone and after repeated oral doses of rabeprazole	Pre dose to up to 48 hours post-dose
Measurement of the area under the plasma concentration by time curve (AUC0-t)	To assess the comparison between AUC0-t following administration of camlipixant alone and after repeated oral doses of rabeprazole	Pre dose to up to 48 hours post-dose
Measurement of the maximum observed plasma drug concentration (Cmax)	To assess the comparison between Cmax following administration of camlipixant alone and after repeated oral doses of rabeprazole	Pre dose to up to 48 hours post-dose

Collaborators and Investigators

• Sponsor: Bellus Health Inc. - a GSK company

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rabeprazole; Rifampin
• Other Study ID Numbers: 221853; BUS-P1-11 (Other Identifier: Bellus Health Inc)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No