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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05959447
Other study ID # 221854
Secondary ID BUS-P1-12
Status Completed
Phase Phase 1
First received
Last updated
Start date July 26, 2023
Est. completion date October 13, 2023

Study information

Verified date February 2024
Source Bellus Health Inc. - a GSK company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 13, 2023
Est. primary completion date October 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Camlipixant + Gemfibrozil
Camlipixant will be administered alone as well as in co-administration with gemfibrozil
Dabigatran etexilate + camlipixant
Dabigatran etexilate will be administered alone as well as in co-administration with camlipixant

Locations

Country Name City State
Canada Syneos Health Québec Quebec

Sponsors (1)

Lead Sponsor Collaborator
Bellus Health Inc. - a GSK company

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 gemfibrozil Pre dose to up to 72 hours post-dose
Primary 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 gemfibrozil Pre dose to up to 72 hours post-dose
Primary 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 gemfibrozil Pre dose to up to 72 hours post-dose
Primary Measurement of the area under the plasma concentration by time curve (AUC0-inf) To assess the comparison between AUC0-inf following administration of dabigatran etexilate alone and after repeated oral doses of camlipixant Pre dose to up to 72 hours post-dose
Primary Measurement of the area under the plasma concentration by time curve (AUC0-t) To assess the comparison between AUC0-t following administration of dabigatran etexilate alone and after repeated oral doses of camlipixant Pre dose to up to 72 hours post-dose
Primary Measurement of the maximum observed plasma drug concentration (Cmax) To assess the comparison between Cmax following administration of dabigatran etexilate alone and after repeated oral doses of camlipixant Pre dose to up to 72 hours post-dose
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