Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gemfibrozil effet on camlipixant pharmacokinetics
|
Drug: Camlipixant + Gemfibrozil
Camlipixant will be administered alone as well as in co-administration with gemfibrozil
|
| Experimental: Camlipixant effect on dabigatran etexilate pharmacokinetics
|
Drug: Dabigatran etexilate + camlipixant
Dabigatran etexilate will be administered alone as well as in co-administration with camlipixant
|
Outcome Measures
Primary Outcome Measures
- Measurement of the area under the plasma concentration by time curve (AUC0-inf) [Pre dose to up to 72 hours post-dose]
To assess the comparison between AUC0-inf following administration of camlipixant alone and after repeated oral doses of gemfibrozil
- Measurement of the area under the plasma concentration by time curve (AUC0-t) [Pre dose to up to 72 hours post-dose]
To assess the comparison between AUC0-t following administration of camlipixant alone and after repeated oral doses of gemfibrozil
- Measurement of the maximum observed plasma drug concentration (Cmax) [Pre dose to up to 72 hours post-dose]
To assess the comparison between Cmax following administration of camlipixant alone and after repeated oral doses of gemfibrozil
- Measurement of the area under the plasma concentration by time curve (AUC0-inf) [Pre dose to up to 72 hours post-dose]
To assess the comparison between AUC0-inf following administration of dabigatran etexilate alone and after repeated oral doses of camlipixant
- Measurement of the area under the plasma concentration by time curve (AUC0-t) [Pre dose to up to 72 hours post-dose]
To assess the comparison between AUC0-t following administration of dabigatran etexilate alone and after repeated oral doses of camlipixant
- Measurement of the maximum observed plasma drug concentration (Cmax) [Pre dose to up to 72 hours post-dose]
To assess the comparison between Cmax following administration of dabigatran etexilate alone and after repeated oral doses of camlipixant
Eligibility Criteria
Criteria
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.- BUS-P1-12