An Investigational Study of Experimental Medication BMS-9... | NCT03660436

Studies
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

NCT03660436

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Dec 19, 2018Actual

Enrollment

131Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

BMS-986165
MMF

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

Dec 2018

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

Aug 14, 2018Actual

Primary Completion Date

Oct 10, 2018Actual

Completion Date

Oct 18, 2018Actual

First Submitted Date

Sep 4, 2018

First Submission Date that Met QC Criteria

Sep 4, 2018

First Posted Date

Sep 6, 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

Dec 17, 2018

Last Update Posted Date

Dec 19, 2018Actual

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

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-986165 + MMF	Experimental	Oral administration	Drug: BMS-986165 Drug: MMF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986165	Drug	Specified dose on specified days	BMS-986165 + MMF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)		18 days
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA		18 days
AUC extrapolated to infinity (AUC[INF]) of MPA		18 days

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events (AE)		Up to 48 days
Number of serious adverse events (SAE)		Up to 48 days
Number of AEs leading to discontinuation

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 deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2

Exclusion Criteria:

Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
Positive anti- John Cunningham virus (JCV) antibody test at Screening
History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply

Accepts Healthy Volunteers

Yes

Sex

Male

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

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

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
Investigator Inquiry Form

ID	Term
C000628674	deucravacitinib
D009173	Mycophenolic Acid

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals