Healthy volunteersFirst-in-humanDrugPhase 1
What this study is
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
What's being tested
- BMS-985521
Intervention · DRUG
Specified dose on specified days.
- Placebo
Intervention · OTHER
Specified dose on specified days
Study details
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants
- Sponsor
- Bristol-Myers Squibb
- Conditions
- Healthy Volunteers
- Enrolling
- 106 people
- Starts
- 2025-12-23
- Est. completion
- 2026-11-17
- Design
- Quadruple-blind, randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
- Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
- For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.
You can't join if
- Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
- Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
- Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
- Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openCenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, United States
- Peter Winkle, Site 0001 · Contact949-295-7809
Recruiting
Study team
Sponsor
Bristol-Myers Squibb
Study ID CN014-0001
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain the NCT# and Site #.
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.