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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT06411730

Run by

Celgene

People needed

56

Starts

2024-05-31

Expected to finish

2024-10-28

Last updated by the study team

2024-11-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0001 — Anaheim, California, United States

Full record on ClinicalTrials.gov

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