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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal

Healthy Volunteers

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Dimebon 5mg in healthy controls

Mild Hepatic Impairment

Mild hepatic impairment patients

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Dimebon 5mg in mild hepatic impairment patients

Moderate hepatic Impairment

Moderate Hepatic Impairment Patients

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Dimebon 5mg in moderate hepatic impairment patients

Severe Hepatic Impairment

Severe Hepatic Impairment Patients

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Dimebon 5mg in Severe Hepatic Impairment

Interventions

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Dimebon

Dimebon 5mg in healthy controls

Intervention Type DRUG

Dimebon

Dimebon 5mg in mild hepatic impairment patients

Intervention Type DRUG

Dimebon

Dimebon 5mg in moderate hepatic impairment patients

Intervention Type DRUG

Dimebon

Dimebon 5mg in Severe Hepatic Impairment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy (healthy is defined as the absence of clinically-relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG and clinical laboratory tests).
* Free of any medical or surgical conditions that might significantly interfere with gastrointestinal absorption, distribution, metabolism, or excretion of Dimebon.
* Demographically comparable to subjects with mild and moderate hepatic impairment.
* Subjects with hepatic impairment: Screening medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests performed within 28 days before the first dose of study medication, abnormal findings that are related to the subject's underlying condition are acceptable.
* Satisfy the criteria for Class A, B, or C of the modified Child-Pugh classification \[Mild (Child-Pugh Scores 5-6 points), moderate (Child-Pugh Scores 7-9 points), and severe (Child-Pugh Scores \>9 and \<12 points)\] within 14 days before the first dose of study medication.
* A diagnosis of hepatic impairment due to cirrhosis, not secondary to other diseases, which is confirmed and documented by medical history, physical examination, liver biopsy or hepatic ultrasound, CT scan or MRI.

Exclusion Criteria

* Subjects presenting with any of the following will not be included in the trial:CYP2D6 PM genotype, as identified by screening genotyping.
* A known sensitivity to Dimebon.
* Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
* History of febrile illness within 5 days prior to the first dose.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes