CompletedPhase 1

A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

United States24 participantsStarted 2024-05-30

Plain-language summary

The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.

Who can participate

Age range

18 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator * Participants will require a left ventricular ejection fraction of \> 50% at screening. * Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2. Exclusion Criteria: * Any current or recent significant acute or chronic illness. * Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, 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. * History of allergy to BMS-986365 or related compounds. Other protocol-defined Inclusion/Exclusion criteria apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum observed concentration (Cmax)

Timeframe: Up to Day 60

Time of maximum observed concentration (Tmax)

Timeframe: Up to Day 60

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Timeframe: Up to Day 60

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))

Timeframe: Up to Day 60

Apparent terminal plasma half-life (T-HALF)

Timeframe: Up to Day 60

Total body clearance (CLT)

Timeframe: Up to Day 15

Apparent total body clearance (CLT/F)

Timeframe: Up to Day 60

Trial details

NCT IDNCT06433505

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-14

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum observed concentration (Cmax)

Timeframe: Up to Day 60

Time of maximum observed concentration (Tmax)

Timeframe: Up to Day 60

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Timeframe: Up to Day 60

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))

Timeframe: Up to Day 60

Apparent terminal plasma half-life (T-HALF)

Timeframe: Up to Day 60

Total body clearance (CLT)

Timeframe: Up to Day 15

Apparent total body clearance (CLT/F)

Timeframe: Up to Day 60