Healthy Participants
Conditions
Keywords
Pharmacokinetics, Pharmacodynamics, Healthy Participants, BMS-986447
Brief summary
The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
Interventions
DRUGBMS-986447
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18 and 30 kilograms per metered square (kg/m\^2), inclusive. * Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations. * A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.
Exclusion criteria
* Participant has any condition that confounds the ability to interpret data from the study. * Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study. * Any major surgery or planned surgery (except gastrointestinal \[GI\] surgery, as described below) within 12 weeks of study intervention administration. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to 34 days |
| Number of Participants with Clinical Laboratory Abnormalities | Up to 34 days |
| Number of Participants with Vital Sign Abnormalities | Up to 35 days |
| Number of Participants with Physical Examination Abnormalities | Up to 35 days |
| Number of Participants with Adverse Events (AEs) | Up to 59 days |
| Number of Participants with Serious AEs (SAEs) | Up to 59 days |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 72 hours postdose |
| Apparent terminal phase half-life (T-Half) | Up to 72 hours postdose |
| Maximum observed plasma concentration (Cmax) | Up to 72 hours postdose |
Countries
United States
Outcome results
None listed