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Gemfibrozil effet on camlipixant pharmacokinetics for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Bellus Health Inc. - a GSK company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre dose to up to 72 hours post-dose
Awards & highlights
Study Summary
This trial tests how safe a drug is by studying how it interacts with existing drugs in healthy people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre dose to up to 72 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre dose to up to 72 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of the area under the plasma concentration by time curve (AUC0-inf)
Measurement of the area under the plasma concentration by time curve (AUC0-t)
Measurement of the maximum observed plasma drug concentration (Cmax)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Gemfibrozil effet on camlipixant pharmacokineticsExperimental Treatment1 Intervention
Group II: Camlipixant effect on dabigatran etexilate pharmacokineticsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Camlipixant + Gemfibrozil
2023
Completed Phase 1
~40
Dabigatran etexilate + camlipixant
2023
Completed Phase 1
~40
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Bellus Health Inc. - a GSK companyLead Sponsor
17 Previous Clinical Trials
5,306 Total Patients Enrolled
Bellus Health IncLead Sponsor
15 Previous Clinical Trials
5,240 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant history of hormone-related health problems.You have a history of a serious immune system disorder.You have a serious history of stomach or digestive problems.You have a history of a serious respiratory disorder.You have a history of serious mental health problems.You have a significant history of kidney problems.You have a history of a significant neurological disorder.You have a history of a significant metabolic disorder that has been diagnosed and treated by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Gemfibrozil effet on camlipixant pharmacokinetics
- Group 2: Camlipixant effect on dabigatran etexilate pharmacokinetics
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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