A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

Healthy Participants Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05546151
• Other study ID #: IM032-042
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2022
• Est. completion date: April 7, 2023

Study information

• Verified date: June 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 7, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Participant must be of Japanese descent (both biological parents are ethnically Japanese).

• In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.

• Women should be of non-childbearing potential.

Exclusion Criteria:

• 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 major surgery within 90 days of study drug administration.

Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986322
Specified dose on specified days

Other:
• Placebo for BMS-986322
Specified dose on specified days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials Llc	Anaheim	California

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 serious adverse events (SAEs)		Up to 7 weeks
Primary	Number of participants with adverse events (AEs) leading to discontinuation		Up to 7 weeks
Primary	Number of deaths		Up to 7 weeks
Primary	Number of participants with AEs		Up to 7 weeks
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 7 weeks
Primary	Number of participants with vital sign abnormalities		Up to 7 weeks
Primary	Number of participants with physical examination abnormalities		Up to 7 weeks
Primary	Number of participants with clinical laboratory abnormalities		Up to 7 weeks
Secondary	Maximum observed plasma concentration (Cmax)		Day 1 and Day 14
Secondary	Time of maximum observed plasma concentration (Tmax)		Day 1 and Day 14
Secondary	Area under the concentration-time curve within a dosing interval (AUC[TAU])		Day 1 and Day 14

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting