Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Comparative Bioavailability, BMS-986278
Brief summary
This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.
Interventions
DRUGBMS-986278 Batched method, Dose A
Specified dose on specified days
DRUGBMS-986278 Batched method, Dose B
Specified dose on specified days
DRUGBMS-986278 Continuous method
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator. * Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. * Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Exclusion criteria
* Any significant acute or chronic medical illness as determined by the investigator. * Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: uncomplicated appendectomy and hernia repair are acceptable). * Any major surgery within 4 weeks of study intervention administration on Day 1, including GI surgery (eg, cholecystectomy and any other GI surgery or perforation that could impact upon the absorption of study intervention \[uncomplicated appendectomy and hernia repair are acceptable\]). * History of known risk of bleeding. * Inability to tolerate oral medication. * Individuals (only females) who are of childbearing potential. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Up to Day 24 |
| Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T)) | Up to Day 24 |
| Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF)) | Up to Day 24 |
Secondary
| Measure | Time frame |
|---|---|
| Time of Maximum Observed Plasma Concentration (Tmax) | Up to Day 24 |
| Terminal Phase Half-life (T-HALF) | Up to Day 24 |
| Apparent Total Body Clearance (CLT/F) | Up to Day 24 |
| Apparent Volume of Distribution (Vz/F) | Up to Day 24 |
| Number of Participants With Adverse Events (AEs) | Up to 28 Days Post-discontinuation of Study Intervention |
| Number of Participants With Clinical Laboratory Abnormalities | Up to Day 25 |
| Number of Participants With Vital Sign Abnormalities | Up to Day 25 |
| Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities | Up to Day 25 |
Countries
United States
Outcome results
None listed