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BMS-986365 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height [m])2.
Be between 18 and 65 years old
Must not have
Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrhythmias, or prolonged QTcF interval (> 450 ms) at screening
Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 60
Awards & highlights

Summary

This trial aims to understand how the body processes and absorbs a drug called BMS-986365. The study will look at how the drug is broken down in the body, how it is eliminated,

Who is the study for?
This trial is for healthy male participants. Specific eligibility criteria are not provided, but typically such studies require individuals without significant health issues who can comply with the study requirements.
What is being tested?
The study is testing BMS-986365 and related compounds to understand how they're processed in the body (pharmacokinetics), their availability when taken orally (bioavailability), and how they're eliminated from the body.
What are the potential side effects?
Since this is a pharmacokinetic study of a new drug in healthy volunteers, potential side effects aren't listed. However, common side effects may include reactions at the administration site, nausea, headache or other mild symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18.0 and 32.0.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of serious heart conditions or a long QT interval.
Select...
I have not had recent GI diseases or surgeries that could affect drug absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute bioavailability (F)
Apparent terminal plasma half-life (T-HALF)
Apparent total body clearance (CLT/F)
+8 more
Secondary study objectives
Number of participants with AEs leading to discontinuation
Number of participants with Adverse Events
Number of participants with Serious Adverse Events
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part B - Arm 2Experimental Treatment1 Intervention
Group II: Part B - Arm 1Experimental Treatment1 Intervention
Group III: Part AExperimental Treatment2 Interventions

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
130,525 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,559 Previous Clinical Trials
3,383,692 Total Patients Enrolled
~0 spots leftby Sep 2024
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