An Investigational Study to Evaluate the Effect of Rifamp... | NCT03563950

Studies
An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants

NCT03563950

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Aug 29, 2018Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

Rifampin
BMS-986224

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

Aug 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

Jun 1, 2018Actual

Primary Completion Date

Jul 27, 2018Actual

Completion Date

Jul 27, 2018Actual

First Submitted Date

Jun 11, 2018

First Submission Date that Met QC Criteria

Jun 11, 2018

First Posted Date

Jun 20, 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

Aug 28, 2018

Last Update Posted Date

Aug 29, 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

Description Module

Brief Summary

The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.

Detailed Description

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rifampin + BMS-986224	Experimental	Oral administration	Drug: Rifampin Drug: BMS-986224

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifampin	Drug	Specified dose on specified days	Rifampin + BMS-986224

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986224		5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224		5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224		5 days

Secondary Outcomes

Measure	Description	Time Frame
Biomarker plasma concentrations of BMS-986224		5 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224		5 days
Terminal elimination half-life (T-HALF) of BMS-986224

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 medical history, physical examination, ECGs, and clinical laboratory determinations
Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

Women of childbearing potential
Any significant acute or chronic medical illness
Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy

Other protocol defined inclusion/exclusion criteria may 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
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
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds