Clinical trial NCT04550195: A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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/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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 30 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 81 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 30 days
measure: Number of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 51 days
measure: Number of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 51 days
measure: Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
timeFrame: Up to 51 days
measure: Number of clinically significant changes from baseline in vital signs: Heart Rate
timeFrame: Up to 51 days
measure: Number of clinically significant changes from baseline in vital signs: Body Temperature
timeFrame: Up to 51 days
measure: Number of clinically significant changes from baseline in vital signs: Blood Pressure
timeFrame: Up to 51 days
measure: Number of clinically significant changes from baseline in vital signs: Respiratory Rate
timeFrame: Up to 51 days
measure: Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
timeFrame: Up to 51 days
measure: Number of clinically significant changes from baseline in physical examinations
timeFrame: Up to 51 days
measure: Number of clinically significant changes in ECG parameters: PR interval
timeFrame: Up to 51 days
measure: Number of clinically significant changes in ECG parameters: QRS duration
timeFrame: Up to 51 days
measure: Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)
timeFrame: Up to 51 days
measure: Number of clinically significant changes in ECG parameters: QT interval
timeFrame: Up to 51 days
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON Plc (PRA Health Sciences) - Netherlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: