NCT00825084

A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects

A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The secondary objective of this study is to compare the pharmacokinetics, safety and tolerability of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.

Conditions

• Alzheimer's Disease
• Huntington's Disease

Interventions

Type	Name	Description
DRUG	Dimebon	dose escalation of single oral doses of 5, 10 and 20 mg
DRUG	Dimebon	dose escalation of single oral doses of 5, 10 and 20 mg
DRUG	Dimebon	10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
DRUG	Dimebon	10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-01-19
• Last updated: 2011-04-26

Locations

1 site across 1 country: United States