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
- Registration Number
- NCT06877702
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
Not provided
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 2: Optional Treatment C BMS-986460 - Part 2: Optional Treatment D BMS-986460 - Part 1: Sequence 1 BMS-986460 - Part 1: Sequence 2 BMS-986460 - Part 1: Sequence 3 BMS-986460 - Part 2: Treatment A BMS-986460 - Part 2: Treatment B BMS-986460 - Part 2: Optional Treatment E BMS-986460 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (2)
ICON Lenexa
🇺🇸Lenexa, Kansas, United States
Local Institution - 0002
🇺🇸Lenexa, Kansas, United States