A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part A Single Ascending Dose (SAD) Cohort A1
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part A SAD Cohort A2
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part A SAD Cohort A3
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part A SAD Cohort A4
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part A SAD Cohort A5
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part A SAD Cohort A6
|
Drug: BMS-986337
Specified Dose on Specified Days
Biological: Famotidine
Specified Dose on Specified Days
|
Experimental: Part B Multiple Ascending Dose (MAD) Cohort B1
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part B MAD Cohort B2
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part B MAD Cohort B3
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part B MAD Cohort B4
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part C MAD in Japanese Healthy participants Cohort C1
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part C MAD in Japanese Healthy participants Cohort C2
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Experimental: Part C MAD in Japanese Healthy participants Cohort C3
|
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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/m2 to 30.0 kg/m2, 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | ICON Plc (PRA Health Sciences) - Netherlands | Groningen | Netherlands | 9728 NZ |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM037-009
- 2019-004518-32