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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04550195
Other study ID # IM037-009
Secondary ID 2019-004518-32
Status Completed
Phase Phase 1
First received
Last updated
Start date September 17, 2020
Est. completion date March 3, 2021

Study information

Verified date February 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 3, 2021
Est. primary completion date March 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986337
Specified Dose on Specified Days
Other:
BMS-986337 Placebo
Specified Dose on Specified Days
Biological:
Famotidine
Specified Dose on Specified Days

Locations

Country Name City State
Netherlands ICON Plc (PRA Health Sciences) - Netherlands Groningen

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events (AEs) Up to 30 days
Primary Incidence of Serious Adverse Events (SAEs) Up to 81 days
Primary Incidence of AEs leading to discontinuation Up to 30 days
Primary Number of clinically significant changes in clinical laboratory values: Hematology tests Up to 51 days
Primary Number of clinically significant changes in clinical laboratory values: Urinalysis tests Up to 51 days
Primary Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests Up to 51 days
Primary Number of clinically significant changes from baseline in vital signs: Heart Rate Up to 51 days
Primary Number of clinically significant changes from baseline in vital signs: Body Temperature Up to 51 days
Primary Number of clinically significant changes from baseline in vital signs: Blood Pressure Up to 51 days
Primary Number of clinically significant changes from baseline in vital signs: Respiratory Rate Up to 51 days
Primary Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR) Up to 51 days
Primary Number of clinically significant changes from baseline in physical examinations Up to 51 days
Primary Number of clinically significant changes in ECG parameters: PR interval PR interval is the time from the onset of the P wave to the start of the QRS complex Up to 51 days
Primary Number of clinically significant changes in ECG parameters: QRS duration QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization Up to 51 days
Primary Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's) 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. Up to 51 days
Primary Number of clinically significant changes in ECG parameters: QT interval The QT interval is the time from the start of the Q wave to the end of the T wave. Up to 51 days
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