A Study to Evaluate the Safety, Tolerability, Drug Levels... | NCT05813717

Studies
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants

NCT05813717

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Nov 7, 2023Actual

Enrollment

25Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

BMS-986325
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2023Actual

Primary Completion Date

Oct 2, 2023Actual

Completion Date

Oct 2, 2023Actual

First Submitted Date

Apr 3, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2023

Last Update Posted Date

Nov 7, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Cohort J1	Experimental	Drug: BMS-986325 Drug: Placebo
Cohort J2	Experimental	Drug: BMS-986325 Drug: Placebo
Cohort J3	Experimental	Drug: BMS-986325 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986325	Drug	Specified dose on specified days	Cohort J1 Cohort J2 Cohort J3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Adverse events		Up to day 92
Number of participants with clinical laboratory abnormalities		Up to day 64
Number of participants with vital sign abnormalities		Up to day 64
Number of participants with ECG abnormalities		Up to day 64
Number of participants with physical examination abnormalities		Up to day 64

Secondary Outcomes

Measure	Description	Time Frame
Serum concentrations of BMS-986325		Up to day 64
Maximum observed serum concentration (Cmax)		Up to day 64
Time of maximum observed serum concentration (Tmax)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.

Exclusion Criteria:

Any significant acute or chronic medical illness.
Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).

Other protocol-defined inclusion/exclusion criteria apply.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0001		Cypress	California	90630	United States

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
FDA Safety Alerts and Recalls