NCT00831506

Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study has been designed to confirm, in healthy subjects, the lack of a clinically important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a sensitive P-gp substrate recommended by FDA.

Conditions

• Alzheimer Disease
• Huntington Disease

Interventions

Type	Name	Description
DRUG	digoxin	digoxin once daily (0.125 mg QD) plus placebo three times daily (TID), 8 hours apart for 14 days.
DRUG	digoxin	digoxin once daily (0.125 mg QD) for 14 days.
DRUG	dimebon	Dimebon three times a day, 8 hours apart for 14 days (10 mg TID on Days 1-7 and 20 mg TID on Days 8-14).

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-01-29
• Last updated: 2009-06-12

Locations

1 site across 1 country: United States