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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959447
• Other study ID #: 221854
• Secondary ID: BUS-P1-12
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy

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