A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986368

Study type: Interventional

Funder types: Industry

Identifiers

NCT06411730

IM045-1009

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants must be healthy male or non-pregnant and non-nursing female individuals.
• For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).
• Participants must have a body mass index (BMI) of 18.0 kg/m2 to 33.0 kg/m2, inclusive.
• Participants must have normal renal function at screening.

Exclusion Criteria

• Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder.
• Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.
• Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.
• Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.
• Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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56 participants in 9 patient groups

Cohort 1A

Experimental group

Treatment:

Drug: BMS-986368

Cohort 1B

Experimental group

Treatment:

Drug: BMS-986368

Cohort 1C

Experimental group

Treatment:

Drug: BMS-986368

Cohort 2A

Experimental group

Treatment:

Drug: BMS-986368

Cohort 2B

Experimental group

Treatment:

Drug: BMS-986368

Cohort 2C

Experimental group

Treatment:

Drug: BMS-986368

Cohort 2D

Experimental group

Treatment:

Drug: BMS-986368

Cohort 3A

Experimental group

Treatment:

Drug: BMS-986368

Cohort 3B

Experimental group

Treatment:

Drug: BMS-986368