Evaluating the safety and drug levels of a new formulation in healthy men
A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)
This study is testing a new version of a medication in healthy men to see how safe it is and how well their bodies absorb it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 2 sites (Lenexa, Kansas and 1 other locations) |
| Trial ID | NCT06877702 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and drug levels of different formulations of BMS-986460 in healthy adult males. Participants will receive a single dose of the drug, and the study will measure how well the body absorbs and processes it. The study is designed as a crossover trial, meaning participants may receive multiple formulations at different times. The goal is to determine the relative bioavailability of these formulations.
Who should consider this trial
Good fit: Ideal candidates are healthy adult males aged 18 to 35 with a BMI between 18.0 and 35.0 kg/m2.
Not a fit: Patients with a history of heart conditions or previous exposure to BMS-986460 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved formulations of BMS-986460 that are safer and more effective for future use.
How similar studies have performed: Other studies evaluating drug formulations have shown success in improving bioavailability and safety profiles.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator. * Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive. * Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception. Exclusion Criteria: * Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded. * Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded. * Participants with history of anaphylactic reactions are excluded. * Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded. * Participants with history of Gilbert's syndrome are excluded. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Lenexa, Kansas and 1 other locations
- ICON Lenexa — Lenexa, Kansas, United States (Recruiting)
- Local Institution - 0002 — Lenexa, Kansas, United States (Withdrawn)
Study contacts
- Study coordinator: BMS Study Connect Contact Center, www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.