Healthy Participants Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464
The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
| Status | Recruiting |
| Enrollment | 132 |
| Est. completion date | March 19, 2025 |
| Est. primary completion date | March 15, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Healthy male and female (i e, women not of childbearing potential) participants - Body Mass Index (BMI) of 18 to 32 kg^m2 and total body weight = 50 kg - Parts A, B, and D: Participants without restriction on ethnicity - Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese) Exclusion Criteria: - Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator - Any major surgery within 3 months of study intervention administration - Participation in another clinical trial concurrent with this study Note: Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| United States | Syneos Health | Austin | Texas |
| United States | Local Institution - 0002 | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Up to 28 days | ||
| Primary | Incidence of serious adverse events (SAEs) | Up to 28 days | ||
| Primary | Number of participants with vital sign abnormalities | Up to 28 days | ||
| Primary | Number of participants with physical examination abnormalities | Up to 28 days | ||
| Primary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 28 days | ||
| Primary | Number of participants with clinical laboratory abnormalities | Up to 28 days | ||
| Primary | Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 28 days | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to Day 27 | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to Day 27 | ||
| Secondary | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] | Up to Day 27 | ||
| Secondary | Cerebrospinal fluid (CSF) concentrations | Up to Day 27 | ||
| Secondary | Ratios of CSF to plasma concentrations | Up to 9 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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