Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Camlipixant + Gemfibrozil
* Drug: Dabigatran etexilate + camlipixant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemfibrozil effet on camlipixant pharmacokinetics<br> | Drug: Camlipixant + Gemfibrozil<br>* Camlipixant will be administered alone as well as in co-administration with gemfibrozil<br>|
| Experimental: Camlipixant effect on dabigatran etexilate pharmacokinetics<br> | Drug: Dabigatran etexilate + camlipixant<br>* Dabigatran etexilate will be administered alone as well as in co-administration with camlipixant<br>|

What is the study measuring?
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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 gemfibrozil | Pre dose to up to 72 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 gemfibrozil | Pre dose to up to 72 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 gemfibrozil | Pre dose to up to 72 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 dabigatran etexilate alone and after repeated oral doses of camlipixant | Pre dose to up to 72 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 dabigatran etexilate alone and after repeated oral doses of camlipixant | Pre dose to up to 72 hours post-dose | 
| 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 |