A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

Healthy Volunteers Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Healthy Volunteers

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

External Links

•   BMS Clinical Trial Information
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