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BMS-986278, followed by gemfibrozil for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 33 days
Awards & highlights

Study Summary

This trial looks at how certain drugs interact with BMS-986278, a single-dose drug, in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 33 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Maximum observed plasma concentration (Cmax)
Secondary outcome measures
Number of participants with adverse events (AEs)
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: BMS-986278, followed by itraconazoleExperimental Treatment2 Interventions
Group II: BMS-986278, followed by gemfibrozilExperimental Treatment2 Interventions
Group III: BMS-986278, followed by carbamazepineExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbamazepine
2016
Completed Phase 4
~2690
Gemfibrozil
2011
Completed Phase 2
~630
BMS-986278
2023
Completed Phase 2
~750
Itraconazole
2017
Completed Phase 2
~780

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,453 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to individuals under the age of sixty?

"Participants in the study must be of age (18+) and not beyond retirement years (65-)."

Answered by AI

Has the administration certified BMS-986278 in combination with carbamazepine?

"As BMS-986278 and carbamazepine are both in the early stages of clinical trials, there is limited data on their safety; therefore our team assigned them a score of 1."

Answered by AI

Are enrollees currently sought for this clinical trial?

"Clinicaltrials.gov reports that this investigation is actively looking for participants; the trial was first publicized on July 12th of 2023 and its details were most recently edited on September 20th around the same year."

Answered by AI

How many participants have been enrolled in this clinical trial?

"Affirmative, clinicaltrials.gov displays that this medical experiment is presently in search of volunteers. It was initially advertised on July 12th 2023 and the most recent update happened on September 20th 2023. This trial needs 48 participants to be recruited from a single site."

Answered by AI

Would I be eligible to take part in this research project?

"48 volunteers meeting the following criteria are being accepted for this study. Candidates must have a BMI between 18 and 32 kg/m^2, with males needing to weigh at least 50kg and females no less than 45kg. This calculation is done through dividing an individual's mass by their height squared (BMI = weight [kg]/(height [m])²)."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
2023. "A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05932303.
~27 spots leftby Apr 2025
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