NCT00831532

Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function

A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function. 2. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function. 3. To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic function.

Conditions

• Hepatic Failure

Interventions

Type	Name	Description
DRUG	Dimebon	Dimebon 5mg in healthy controls
DRUG	Dimebon	Dimebon 5mg in mild hepatic impairment patients
DRUG	Dimebon	Dimebon 5mg in moderate hepatic impairment patients
DRUG	Dimebon	Dimebon 5mg in Severe Hepatic Impairment

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-01-29
• Last updated: 2009-09-16

Locations

2 sites across 1 country: United States