A Phase 1 Study To Evaluate The Effect Of Dimebon On The... | NCT00788047

Studies
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

NCT00788047

Sponsor

Pfizer

Status

Completed

Last Update Posted

Mar 9, 2009Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Huntington Disease
Alzheimer Disease

Interventions

Dextromethorphan
Dimebon + Dextromethorphan

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

Mar 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

Nov 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Nov 7, 2008

First Submission Date that Met QC Criteria

Nov 7, 2008

First Posted Date

Nov 10, 2008Estimated

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

Mar 5, 2009

Last Update Posted Date

Mar 9, 2009Estimated

Name	Class
Medivation, Inc.	INDUSTRY

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

This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen A (Reference)	Other		Drug: Dextromethorphan
Regimen B (Test)	Experimental		Drug: Dimebon + Dextromethorphan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextromethorphan	Drug	Dextromethorphan HCl 30 syrup single dose	Regimen A (Reference)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dextromethorphan exposure in combination with Dimebon 20 mg TID relative to Dextromethorphan exposure alone		Day 12

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability (Adverse Events, Vital Signs, Clinical Labs, Electrocardiograms)		Day 15
Dextrorphan (the metabolite of dextromethorphan) exposure		Day 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult subjects.
Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.

Exclusion Criteria:

Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.

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		New Haven	Connecticut	06511	United States

References Module

Citations

Not provided

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D003915	Dextromethorphan
C010119	latrepirdine

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

ID	Term
D006816	Huntington Disease
D000544	Alzheimer Disease