A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT04550195
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Single Ascending Dose (SAD) Cohort A1 BMS-986337 - Part A Single Ascending Dose (SAD) Cohort A1 BMS-986337 Placebo - Part A SAD Cohort A6 Famotidine - Part B MAD Cohort B3 BMS-986337 - Part B MAD Cohort B3 BMS-986337 Placebo - Part C MAD in Japanese Healthy participants Cohort C2 BMS-986337 Placebo - Part C MAD in Japanese Healthy participants Cohort C1 BMS-986337 Placebo - Part C MAD in Japanese Healthy participants Cohort C3 BMS-986337 Placebo - Part A SAD Cohort A2 BMS-986337 - Part A SAD Cohort A3 BMS-986337 Placebo - Part A SAD Cohort A4 BMS-986337 - Part A SAD Cohort A4 BMS-986337 Placebo - Part B MAD Cohort B4 BMS-986337 Placebo - Part A SAD Cohort A2 BMS-986337 Placebo - Part A SAD Cohort A5 BMS-986337 - Part A SAD Cohort A5 BMS-986337 Placebo - Part B MAD Cohort B2 BMS-986337 Placebo - Part B Multiple Ascending Dose (MAD) Cohort B1 BMS-986337 - Part B Multiple Ascending Dose (MAD) Cohort B1 BMS-986337 Placebo - Part B MAD Cohort B2 BMS-986337 - Part C MAD in Japanese Healthy participants Cohort C1 BMS-986337 - Part C MAD in Japanese Healthy participants Cohort C2 BMS-986337 - Part B MAD Cohort B4 BMS-986337 - Part C MAD in Japanese Healthy participants Cohort C3 BMS-986337 - Part A SAD Cohort A3 BMS-986337 - Part A SAD Cohort A6 BMS-986337 -
- Primary Outcome Measures
Name Time Method Number of clinically significant changes from baseline in vital signs: Body Temperature Up to 51 days 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: Urinalysis tests Up to 51 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: 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: 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 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 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: 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ICON Plc (PRA Health Sciences) - Netherlands
🇳🇱Groningen, Netherlands