A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants

A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)

The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986460

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
• Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
• Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.

Exclusion Criteria:

• Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
• Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
• Participants with history of anaphylactic reactions are excluded.
• Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
• Participants with history of Gilbert's syndrome are excluded.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Sequence 1	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 1: Sequence 2	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 1: Sequence 3	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 2: Treatment A	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 2: Treatment B	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 2: Optional Treatment C	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 2: Optional Treatment D	Drug: BMS-986460; Specified dose on specified days.
Experimental: Part 2: Optional Treatment E	Drug: BMS-986460; Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities	Up to approximately Day 21
Part 1: Number of Participants With Adverse Events (AEs)	Up to approximately Day 43
Part 1: Number of Participants With Serious AEs (SAEs)	Up to approximately Day 43
Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings	Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities	Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings	Up to approximately Day 21
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460	Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460	Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460	Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460	Up to approximately Day 21
Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax	Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)	Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)	Up to approximately Day 21
Part 2: Number of Participants With AEs	Up to approximately Day 29
Part 2: Number of Participants With SAEs	Up to approximately Day 29
Part 2: Number of Participants With Clinically Significant PE Findings	Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities	Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities	Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings	Up to approximately Day 7
Part 2: Cmax of BMS-986460	Up to approximately Day 7
Part 2: Tmax of BMS-986460	Up to approximately Day 7
Part 2: AUC [0-T] of BMS-986460	Up to approximately Day 7
Part 2: AUC(INF) of BMS-986460	Up to approximately Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax	Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)	Up to approximately Day 7
Part 2: PK Linearity of BMS-986460 Based on AUC(INF)	Up to approximately Day 7

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Actual): December 17, 2025
• Study Completion (Actual): December 17, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: BMS-986460, bioavailability, healthy adult male, crossover, SAD
• Other Study ID Numbers: CA125-1018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No