Healthy Clinical Trial
Official title:
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
Verified date | February 2024 |
Source | Bellus Health Inc. - a GSK company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Syneos Health | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Bellus Health Inc. - a GSK company |
Canada,
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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