A Study to Evaluate the Safety, Tolerability and Drug Lev... | NCT06086886

Studies
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants

NCT06086886

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Mar 24, 2025Actual

Enrollment

63Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

BMS-986454
Placebo

Countries

United Kingdom

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

ID	Type	Description	Link
U1111-1270-3670	Registry Identifier	WHO

Status Module

Record Verification Date

Mar 2025

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

Nov 16, 2023Actual

Primary Completion Date

Dec 20, 2024Actual

Completion Date

Dec 20, 2024Actual

First Submitted Date

Oct 11, 2023

First Submission Date that Met QC Criteria

Oct 11, 2023

First Posted Date

Oct 17, 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

Mar 21, 2025

Last Update Posted Date

Mar 24, 2025Actual

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

Yes

FDAAA801 Violation

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

63Actual

Label	Type	Description	Intervention Names
BMS-986454	Experimental		Drug: BMS-986454
Placebo	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BMS-986454	Drug	Specified dose on specified days	BMS-986454
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (AEs)		Up to approximately 4 months
Number of participants with severe adverse events (SAEs)		Up to approximately 4 months
Number of participants with physical examination abnormalities		Up to approximately 4 months
Number of participants with vital sign abnormalities		Up to approximately 4 months
Number of participants with electrocardiogram (ECG) abnormalities		Up to approximately 4 months
Number of participants with clinical laboratory abnormalities		Up to approximately 4 months

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed serum concentration (Cmax)		Up to approximately 3 months
Time of maximum observed serum concentration (Tmax)		Up to approximately 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period.
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.

Exclusion Criteria:

Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
Inability to be venipunctured or tolerate venous access.

Note: 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

55 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 - 0002		London	Greater London	NW10 7EW	United Kingdom
Local Institution - 0001

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided