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

Sponsor

Bellus Health Inc (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05899829

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Camlipixant + Rifampin Drug: Camlipixant + Rabeprazole	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Syneos Health	Québec	Quebec	Canada	G1P 0A2

Sponsors and Collaborators

Bellus Health Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bellus Health Inc

ClinicalTrials.gov Identifier:

NCT05899829

Other Study ID Numbers:

BUS-P1-11

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rifampin

Rabeprazole

Study Results

No Results Posted as of Jun 12, 2023