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

NCT00831532 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2009-09-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00831532 on ClinicalTrials.gov