Last updated: 02/21/2025 07:50:29
Evaluation of the potential drug-drug interactions between gemfibrozil or dabigatran etexilate and camlipixant
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Measurement of the area under the plasma concentration by time curve (AUC0-inf)
Timeframe: Pre dose to up to 72 hours post-dose
Measurement of the area under the plasma concentration by time curve (AUC0-t)
Timeframe: Pre dose to up to 72 hours post-dose
Measurement of the maximum observed plasma drug concentration (Cmax)
Timeframe: Pre dose to up to 72 hours post-dose
Measurement of the area under the plasma concentration by time curve (AUC0-inf)
Timeframe: Pre dose to up to 72 hours post-dose
Measurement of the area under the plasma concentration by time curve (AUC0-t)
Timeframe: Pre dose to up to 72 hours post-dose
Measurement of the maximum observed plasma drug concentration (Cmax)
Timeframe: Pre dose to up to 72 hours post-dose
Secondary outcomes:
Not applicable
Interventions:
Drug: Camlipixant
Drug: Dabigatran etexilate
Drug: Gemfibrozil
Enrollment:
45
Observational study model:
Not applicable
Primary completion date:
2023-13-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cough, Healthy
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2023 to October 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- Healthy males or non-pregnant, non-lactating healthy females
- History of clinically significant history of neurological, endocrine,
- cardiovascular, respiratory, hematological, immunological, psychiatric,
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2023-13-10
Actual study completion date
2023-13-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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