Healthy Volunteers
Conditions
Keywords
Healthy volunteers
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.
Interventions
DRUGBMS-986337
Specified Dose on Specified Days
OTHERBMS-986337 Placebo
Specified Dose on Specified Days
BIOLOGICALFamotidine
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese) * Body mass index (BMI) of 18.0 kg/m\^2 to 30.0 kg/m\^2, inclusive, at screening; BMI = weight (kg)/height (m)\^2 * Women and men must agree to follow specific methods of contraception, if applicable
Exclusion criteria
* Women who are of childbearing potential * Women who are breastfeeding * Prior exposure to BMS-986278 * Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 30 days | — |
| Incidence of Serious Adverse Events (SAEs) | Up to 81 days | — |
| Incidence of AEs leading to discontinuation | Up to 30 days | — |
| Number of clinically significant changes in clinical laboratory values: Hematology tests | Up to 51 days | — |
| Number of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 51 days | — |
| Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 51 days | — |
| Number of clinically significant changes from baseline in vital signs: Heart Rate | Up to 51 days | — |
| Number of clinically significant changes from baseline in vital signs: Body Temperature | Up to 51 days | — |
| Number of clinically significant changes from baseline in vital signs: Blood Pressure | Up to 51 days | — |
| Number of clinically significant changes from baseline in vital signs: Respiratory Rate | Up to 51 days | — |
| Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR) | Up to 51 days | — |
| Number of clinically significant changes from baseline in physical examinations | Up to 51 days | — |
| Number of clinically significant changes in ECG parameters: PR interval | Up to 51 days | PR interval is the time from the onset of the P wave to the start of the QRS complex |
| Number of clinically significant changes in ECG parameters: QRS duration | Up to 51 days | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization |
| Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's) | Up to 51 days | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave. |
| Number of clinically significant changes in ECG parameters: QT interval | Up to 51 days | The QT interval is the time from the start of the Q wave to the end of the T wave. |
Countries
Netherlands
Outcome results
None listed