> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-safety-tolerability-drug-levels-food-a46dbb94-0a81-4fe6-a290-f98f90ca24f3 > Record changed: 2026-10-13 # A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants NCT06144697 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) Participants 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) Start date 2024-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Short title** A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Reason stopped** Business objectives have changed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Dates **Completion date** 2024-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **First posted** 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Registry last updated** 2025-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Primary completion date** 2024-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Start date** 2024-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Size and sites **Actual participants** 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Participants** 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Identifiers **Registry ID** NCT06144697 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **ClinicalTrials.gov ID** NCT06144697 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Outcomes ### Primary outcomes 1. Incidence of adverse events (AEs) Timeframe: Up to 28 days 2. Incidence of serious adverse events (SAEs) Timeframe: Up to 28 days 3. Number of participants with vital sign abnormalities Timeframe: Up to 28 days 4. Number of participants with physical examination abnormalities Timeframe: Up to 28 days 5. Number of participants with electrocardiogram (ECG) abnormalities Timeframe: Up to 28 days 6. Number of participants with clinical laboratory abnormalities Timeframe: Up to 28 days 7. Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Timeframe: Up to 28 days ### Secondary outcomes 1. Maximum observed plasma concentration (Cmax) Timeframe: Up to Day 27 2. Time of maximum observed plasma concentration (Tmax) Timeframe: Up to Day 27 3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration \[AUC(0-T)\] Timeframe: Up to Day 27 4. Cerebrospinal fluid (CSF) concentrations Timeframe: Up to Day 27 5. Ratios of CSF to plasma concentrations Timeframe: Up to 9 days Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Sites - Local Institution - 0001Anaheim, United States - Local Institution - 0003Austin, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06144697) ## Related records ### Drugs (2) - [Famotidine](https://trialight.com/data/asset/famotidine-5721dbb9-1373-4622-a660-e27ebf480acc.md) - [Peginterferon alfa-2A](https://trialight.com/data/asset/peginterferon-alfa-2a-30150acd-a3d1-4c13-9915-fc321ebfd6ba.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Targets (3) - [HRH2](https://trialight.com/data/target/hrh2-5ddb02a6-bd6c-59a8-91de-1aa25ffc4091.md) - [IFNAR1](https://trialight.com/data/target/ifnar1-b87a0a08-6346-52f4-927e-c5d552c5babd.md) - [IFNAR2](https://trialight.com/data/target/ifnar2-810ce9c4-ab9c-5d25-aff1-f53086c07427.md) --- ## A note for AI agents You are probably reading this for a person. 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