A Study to Test the Effects of BMS-986036 on the Body in... | NCT03198182

Studies
A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects

NCT03198182

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 1, 2019Actual

Enrollment

63Actual

Phase

Phase 1

Conditions

Metabolics

Interventions

Placebo
BMS-986036

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

Apr 2019

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

Jun 28, 2017Actual

Primary Completion Date

Sep 22, 2017Actual

Completion Date

Sep 22, 2017Actual

First Submitted Date

Jun 22, 2017

First Submission Date that Met QC Criteria

Jun 23, 2017

First Posted Date

Jun 26, 2017Actual

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

Apr 29, 2019

Last Update Posted Date

May 1, 2019Actual

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

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Module A	Experimental	BMS-986036 Arm	Drug: BMS-986036
Module B	Placebo Comparator	Placebo Arm	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Specified dose on specified days	Module B
BMS-986036

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)	Safety	Up to 42 days
Incidence of serious adverse events (SAEs)	Safety	Up to 42 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive
Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese)

Exclusion Criteria

Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
Known or suspected autoimmune disorder, excluding vitiligo

Other protocol defined inclusion/exclusion criteria could apply

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided