Healthy Participants Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | October 8, 2024 |
Est. primary completion date | October 8, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress 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. |
Country | Name | City | State |
---|---|---|---|
United States | Anaheim Clinical Trials (ACT) | Anaheim | California |
Lead Sponsor | Collaborator |
---|---|
Celgene |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events (AEs) | Up to 44 days | ||
Primary | Number of participants with serious adverse events (SAEs) | Up to 44 days | ||
Primary | Number of participants with vital sign (VS) abnormalities | Up to 21 days | ||
Primary | Number of participants with physical examination abnormalities | Up to 21 days | ||
Primary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 21 days | ||
Primary | Number of participants with clinical laboratory asssement abnormalities | Up to 21 days | ||
Primary | Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 21 days | ||
Secondary | Area under the plasma concentration-time curve (AUC) | Up to 16 days | ||
Secondary | Maximum observed plasma concentration (Cmax) | Up to 16 days | ||
Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 16 days | ||
Secondary | Absolute levels of fatty acid amide hydrolase (FAAH) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days | ||
Secondary | Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days | ||
Secondary | Percent change from baseline for fatty acid amide hydrolase (FAAH) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days | ||
Secondary | Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs) | Up to 21 days | ||
Secondary | Plasma concentrations of anandamide (AEA) | Up to 21 days | ||
Secondary | Percent change from baseline of anandamide (AEA) | Up to 21 days | ||
Secondary | Whole blood concentrations of 2-arachidonoylglycerol (2-AG) | Up to 21 days | ||
Secondary | Percent change from baseline of 2-arachidonoylglycerol (2-AG) | Up to 21 days |
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