Drug-Drug Interaction Study in Healthy Subjects | NCT00904059

Studies
Drug-Drug Interaction Study in Healthy Subjects

NCT00904059

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 7, 2011Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Hepatitis C

Interventions

BMS-650032
BMS-790052
BMS-650032
BMS-790052

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 2010

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 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Apr 21, 2009

First Submission Date that Met QC Criteria

May 18, 2009

First Posted Date

May 19, 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

Jan 6, 2011

Last Update Posted Date

Jan 7, 2011Estimated

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 pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone

Detailed Description

Pharmacokinetics and Safety in Healthy Subjects

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group A	Experimental		Drug: BMS-650032
Treatment Group B	Experimental		Drug: BMS-790052
Treatment Group C	Experimental	Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)	Drug: BMS-650032 Drug: BMS-790052

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-650032	Drug	Capsules, Oral, 600 mg, Q12h, Days 1-7	Treatment Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin		Day 21 pharmacokinetic assessment

Secondary Outcomes

Measure	Description	Time Frame
To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered		Within 24 hours post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects aged 18 to 49 years
Females who are not of childbearing potential, pregnant or breastfeeding
Subject Body Mass Index (BMI) of 18 to 32 kg/m²

Exclusion Criteria:

Women of child bearing potential
Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing
Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Prior exposure to BMS-650032 or BMS-790052
Positive for HIV or HCV

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
Ppd Development, Lp		Austin	Texas	78744	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
C571889	asunaprevir
C549273	daclatasvir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided