Study to Assess the Effect of BMS-791325 on the Pharmacok... | NCT00996879

Studies
Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects

NCT00996879

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 6, 2014Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Hepatitis C

Interventions

Midazolam
BMS-791325

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

May 2014

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

May 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

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

May 5, 2014

Last Update Posted Date

May 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Midazolam + BMS-791325	Experimental		Drug: Midazolam Drug: BMS-791325

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug	Syrup, Oral, 5 mg, Single dose, 2 days	Midazolam + BMS-791325

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)		Within 24 hours of dosing

Secondary Outcomes

Measure	Description	Time Frame
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests		On Days 1, 2, 4, 6, 8, 9, and 10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
Women who are not of childbearing potential

Exclusion Criteria:

Women of childbearing potential
Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
Gastrointestinal disease that may impact the absorption of study drug
History of any chronic respiratory disease (asthma, COPD)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 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
Wcct Global, Llc		Cypress	California	90630	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam
C587012	8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided