A Study of Experimental Medication BMS-986036 Given to He... | NCT03445208

Studies
A Study of Experimental Medication BMS-986036 Given to Healthy Participants

NCT03445208

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Mar 19, 2020Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Hepatic Cirrhosis
Liver Fibrosis
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis

Interventions

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

Mar 2020

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

Feb 14, 2018Actual

Primary Completion Date

May 2, 2018Actual

Completion Date

May 2, 2018Actual

First Submitted Date

Feb 20, 2018

First Submission Date that Met QC Criteria

Feb 22, 2018

First Posted Date

Feb 26, 2018Actual

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 17, 2020

Last Update Posted Date

Mar 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental	BMI 18.0 to ≤ 25.0	Drug: BMS-986036
Cohort 2	Experimental	BMI >25.0 to ≤ 30.0	Drug: BMS-986036
Cohort 3	Experimental	BMI >30.0 ≤ 40.0	Drug: BMS-986036

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986036	Drug	Crossover administration to abdomen then upper arm	Cohort 1 Cohort 2 Cohort 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed serum concentration (Cmax)		29 days
Time of maximum observed serum concentration (Tmax)		29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]		29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]		29 days

Secondary Outcomes

Measure	Description	Time Frame
Number of injection site reactions		Up to 78 days
Number of adverse events (AE)		Up to 78 days
Number of serious adverse events (SAE)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
BMI of 18 to ≤ 40 kg/m2

Exclusion Criteria:

Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
Known or suspected autoimmune disorder, excluding vitiligo
Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
Any significant acute or chronic medical illness
Current or recent (within 3 months of study drug administration) gastrointestinal disease
Any major surgery within 6 weeks of study drug administration
History of diabetes mellitus

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

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

Facility	Status	City	State	ZIP	Country	Contacts
PRA Health Sciences		Salt Lake City	Utah	84107	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided