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

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ClinicalTrials.gov Identifier: NCT05959447
Recruitment Status : Completed
First Posted : July 25, 2023
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
Bellus Health Inc. - a GSK company

Study Description
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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
Healthy Drug: Camlipixant + Gemfibrozil Drug: Dabigatran etexilate + camlipixant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 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
Actual Study Start Date : July 26, 2023
Actual Primary Completion Date : October 13, 2023
Actual Study Completion Date : October 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Measurement of the area under the plasma concentration by time curve (AUC0-inf) [ Time Frame: 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

  2. Measurement of the area under the plasma concentration by time curve (AUC0-t) [ Time Frame: 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

  3. Measurement of the maximum observed plasma drug concentration (Cmax) [ Time Frame: 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

  4. Measurement of the area under the plasma concentration by time curve (AUC0-inf) [ Time Frame: 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

  5. Measurement of the area under the plasma concentration by time curve (AUC0-t) [ Time Frame: 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

  6. Measurement of the maximum observed plasma drug concentration (Cmax) [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959447


Locations
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Canada, Quebec
Syneos Health
Québec, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Bellus Health Inc. - a GSK company
More Information
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Responsible Party: Bellus Health Inc. - a GSK company
ClinicalTrials.gov Identifier: NCT05959447    
Other Study ID Numbers: 221854
BUS-P1-12 ( Other Identifier: Bellus Health Inc )
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Gemfibrozil
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anticoagulants
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors