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

NCT06877702 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CA125-1018
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

BMS-986460, bioavailability, healthy adult male, crossover, SAD

Outcome Measures

Primary Outcomes (23)

• 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 Laboratory Assessment 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 Outcomes (3)

• 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

Study Arms (8)

Part 1: Sequence 1

EXPERIMENTAL

Drug: BMS-986460

Part 1: Sequence 2

EXPERIMENTAL

Drug: BMS-986460

Part 1: Sequence 3

EXPERIMENTAL

Drug: BMS-986460

Part 2: Treatment A

EXPERIMENTAL

Drug: BMS-986460

Part 2: Treatment B

EXPERIMENTAL

Drug: BMS-986460

Part 2: Optional Treatment C

EXPERIMENTAL

Drug: BMS-986460

Part 2: Optional Treatment D

EXPERIMENTAL

Drug: BMS-986460

Part 2: Optional Treatment E

EXPERIMENTAL

Drug: BMS-986460

Interventions

BMS-986460 DRUG

Specified dose on specified days.

Part 1: Sequence 1; Part 1: Sequence 2; Part 1: Sequence 3; Part 2: Optional Treatment C; Part 2: Optional Treatment D; Part 2: Optional Treatment E; Part 2: Treatment A; Part 2: Treatment B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 19, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)