An Investigational Study of Experimental Medication BMS-9... | NCT03712540

Studies
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants

NCT03712540

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 12, 2019Actual

Enrollment

39Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

BMS-986278
Rifampin

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

Jun 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

Sep 6, 2018Actual

Primary Completion Date

Nov 8, 2018Actual

Completion Date

Nov 8, 2018Actual

First Submitted Date

Oct 17, 2018

First Submission Date that Met QC Criteria

Oct 17, 2018

First Posted Date

Oct 19, 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

Jun 10, 2019

Last Update Posted Date

Jun 12, 2019Actual

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

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-986278 + Rifampin	Experimental	Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278	Drug: BMS-986278 Drug: Rifampin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-986278	Drug	Oral administration 30 mg	BMS-986278 + Rifampin
Rifampin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration (Cmax) for BMS-986278		Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278		Up to 24 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278		Day 1 and 8
Terminal phase half-life (T-HALF) for BMS-986278		Day 1 and 8

Secondary Outcomes

Measure	Description	Time Frame
Incidence of non-serious adverse events (AE)		Up to 24 days
Incidence of serious adverse events (SAE)		Up to 24 days
Incidence of AE 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:

Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

Women who are of childbearing potential or breastfeeding
Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
History of significant cardiovascular disease
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment

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

65 Years

Standard Ages

AdultOlder 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 Science KK		Lenexa	Kansas	66219	United States

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

Intervention Browse Module

MeSH Terms

ID	Term
D012293	Rifampin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided