Drug Interaction Study Of Filibuvir With Methadone Among... | NCT01210404

Studies
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

NCT01210404

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jun 7, 2011Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Chronic Hepatitis C

Interventions

filibuvir

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 2011

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

Feb 2011

Primary Completion Date

May 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 27, 2010

First Submission Date that Met QC Criteria

Sep 27, 2010

First Posted Date

Sep 28, 2010Estimated

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 6, 2011

Last Update Posted Date

Jun 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

Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1.0	Experimental		Drug: filibuvir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
filibuvir	Drug	Filibuvir, 600mg bid administered along with methadone on days 2-11	1.0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Methadone plasma pharmacokinetic parameters, AUC24, Cmax		day 1
Methadone plasma pharmacokinetic parameters, AUC24, Cmax		day 11

Secondary Outcomes

Measure	Description	Time Frame
Methadone plasma pharmacokinetic parameters Tmax and C24h		day 1
Methadone plasma pharmacokinetic parameters Tmax and C24h		day 11
Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.

Exclusion Criteria:

Evidence of chronic diseases including HIV, HBV or HCV.
Evidence of acute or chronic liver disease.
Treatment with prescription or nonprescription drugs other than methadone within 7 days.

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
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Overland Park	Kansas	66211	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections