Healthy Volunteers
Conditions
Keywords
BMS-986460, bioavailability, healthy adult male, crossover, SAD
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.
Interventions
DRUGBMS-986460
Specified dose on specified days.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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(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
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed