Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444050
• Other study ID #: CV023-005
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: October 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, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations

• A body mass index of 18 - 32 kg/m2, inclusive

• Women and men must agree to follow specific methods of contraception, if applicable

For J-MAD Part 3

• Must be Japanese (both biological parents are ethnically Japanese)

Exclusion Criteria:

• Women who are of childbearing potential

• Women who are pregnant or breastfeeding

• Any significant acute or chronic medical illness

• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug

• Any surgery within 12 weeks of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986331
Specified dose on specified days

Other:
• Placebo, Matching BMS-986331
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Anaheim	California
United States	ICON (LPRA) - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to 13 months
Primary	Number of participants with clinical laboratory abnormalities		Up to 46 days
Primary	Number of participants with vital sign abnormalities		Up to 46 days
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 46 days
Secondary	Maximum plasma concentration (Cmax)		Up to 17 days
Secondary	Time to reach Cmax in plasma (Tmax)		Up to 17 days
Secondary	Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]		Up to 17 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form