Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole | NCT00860275

Studies
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

NCT00860275

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Alzheimer Disease

Interventions

BMS-708163
BMS-708163 + Ketoconazole
Ketoconazole
Fluconazole
BMS-708163 + Fluconazole

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

Jul 2009

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

Apr 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 11, 2009

First Submission Date that Met QC Criteria

Mar 11, 2009

First Posted Date

Mar 12, 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 24, 2011

Last Update Posted Date

Jan 25, 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 the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-708163 / Ketoconazole	Active Comparator		Drug: BMS-708163 Drug: BMS-708163 + Ketoconazole Drug: Ketoconazole
BMS-708163 / Fluconazole	Active Comparator		Drug: BMS-708163 Drug: Fluconazole Drug: BMS-708163 + Fluconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-708163	Drug	Capsule, Oral, 50 mg, once, Day 1	BMS-708163 / Fluconazole BMS-708163 / Ketoconazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK profile of BMS-708163		Within 14 days after dose

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole		During the entire study period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and postmenopausal female subjects 18-55 yrs old inclusive

Exclusion:

Premenopausal women

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
Ppd Development, Lp		Austin	Texas	78744	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C554092	BMS 708163
D007654	Ketoconazole
D015725	Fluconazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014230	Triazoles

Browse Leaves

Not provided

Browse Branches

Not provided