A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Alzheimer's DiseaseHuntington's Disease
Interventions
DRUG

Dimebon alone

Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening

DRUG

Dimebon + Ketoconazole

Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 4 during the daily administration of ketoconazole (400 mg, Day 1-11) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening

DRUG

Dimebon + Omeprazole

Pharmacokinetics of a single oral dose of 10 mg Dimebon (tablet) will be assessed on Day 5 during the daily administration of omeprazole(40 mg, Day 1-12) in subjects with a CYP2D6 extensive and poor metabolizer status based on genotyping as screening

Trial Locations (1)

49007

Pfizer Investigational Site, Kalamazoo

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medivation, Inc.

INDUSTRY

lead

Pfizer

INDUSTRY