ICON Plc (PRA Health Sciences) - Netherlands
Groningen, 9728 NZ, Netherlands
Completed
NCT Number: NCT04550195
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
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.
Completed
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Notify MeKey information
Conditions
Age range
21 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BMS-986337
DrugSpecified Dose on Specified Days
BMS-986337 Placebo
OtherSpecified Dose on Specified Days
Famotidine
BiologicalSpecified Dose on Specified Days
Primary outcomes
-
Incidence of Adverse Events (AEs)
Time frame: Up to 30 days
-
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 81 days
-
Incidence of AEs leading to discontinuation
Time frame: Up to 30 days
-
Number of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 51 days
-
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 51 days
-
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 51 days
-
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time frame: Up to 51 days
-
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time frame: Up to 51 days
-
Number of clinically significant changes from baseline in vital signs: Blood Pressure
Time frame: Up to 51 days
-
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time frame: Up to 51 days
-
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
Time frame: Up to 51 days
-
Number of clinically significant changes from baseline in physical examinations
Time frame: Up to 51 days
-
Number of clinically significant changes in ECG parameters: PR interval
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Up to 51 days
The QT interval is the time from the start of the Q wave to the end of the T wave.
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Sep 16, 2020
- Registry last updated
- Feb 25, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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