Healthy Volunteers
Conditions
Keywords
BMS-986419, Healthy male of non-child bearing potential, Healthy women of non-child bearing potential
Brief summary
The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.
Interventions
DRUGBMS-986419 DR Capsule
Specified dose on specified days
DRUGBMS-986419 IR Tablet
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations. * Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, and body weight ≥ 50 kg. * A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)
Exclusion criteria
* Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator. * Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure). * History of Gilbert's syndrome. * Women who are of childbearing potential and women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 15 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to 15 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with clinical laboratory abnormalities | Up to 29 days |
| Number of participants with physical examination abnormalities | Up to 29 days |
| Number of participants with adverse events (AEs) | Up to 29 days |
| Terminal half-life (T-Half) | Up to 15 days |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) | Up to 15 days |
| Time to attain maximum observed plasma concentration (Tmax) | Up to 15 days |
| Number of participants with vital sign abnormalities | Up to 29 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 29 days |
Countries
United States
Outcome results
None listed