A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-985521; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07283263

CN014-0001

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Other protocol defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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106 participants in 12 patient groups

Part A Cohort 1

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part A Cohort 2

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part A Cohort 3

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part A Cohort 4

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part A Cohort 5

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part A Cohort 6

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part B Cohort 7

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part B Cohort 8

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part B Cohort 9

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part B Cohort 10

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part B Cohort 11

Experimental group

Treatment:

Other: Placebo

Drug: BMS-985521

Part C

Experimental group

Treatment:

Drug: BMS-985521