Clinical trial NCT06877702: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986460, bioavailability, healthy adult male, crossover, SAD
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately Day 43
measure: Part 1: Number of Participants With Serious AEs (SAEs)
timeFrame: Up to approximately Day 43
measure: Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings
timeFrame: Up to approximately Day 21
measure: Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Up to approximately Day 21
measure: Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
timeFrame: Up to approximately Day 21
measure: Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
timeFrame: Up to approximately Day 21
measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460
timeFrame: Up to approximately Day 21
measure: Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460
timeFrame: Up to approximately Day 21
measure: Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460
timeFrame: Up to approximately Day 21
measure: Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460
timeFrame: Up to approximately Day 21
measure: Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax
timeFrame: Up to approximately Day 21
measure: Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)
timeFrame: Up to approximately Day 21
measure: Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)
timeFrame: Up to approximately Day 21
measure: Part 2: Number of Participants With AEs
timeFrame: Up to approximately Day 29
measure: Part 2: Number of Participants With SAEs
timeFrame: Up to approximately Day 29
measure: Part 2: Number of Participants With Clinically Significant PE Findings
timeFrame: Up to approximately Day 7
measure: Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Up to approximately Day 7
measure: Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
timeFrame: Up to approximately Day 7
measure: Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings
timeFrame: Up to approximately Day 7
measure: Part 2: Cmax of BMS-986460
timeFrame: Up to approximately Day 7
measure: Part 2: Tmax of BMS-986460
timeFrame: Up to approximately Day 7
measure: Part 2: AUC [0-T] of BMS-986460
timeFrame: Up to approximately Day 7
measure: Part 2: AUC(INF) of BMS-986460
timeFrame: Up to approximately Day 7
Secondary outcomes:
measure: Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax
timeFrame: Up to approximately Day 7
measure: Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)
timeFrame: Up to approximately Day 7
measure: Part 2: PK Linearity of BMS-986460 Based on AUC(INF)
timeFrame: Up to approximately Day 7
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
city: Lenexa
country: United States
facility: Local Institution - 0002
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: