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

Study Overview
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Brief Summary
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To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function. To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic function.

Official Title
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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

Conditions
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Hepatic Failure

Intervention / Treatment
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* Drug: Dimebon
* Drug: Dimebon
* Drug: Dimebon
* Drug: Dimebon


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal<br>Healthy Volunteers | Drug: Dimebon<br>* Dimebon 5mg in healthy controls<br>|
| Experimental: Mild Hepatic Impairment<br>Mild hepatic impairment patients | Drug: Dimebon<br>* Dimebon 5mg in mild hepatic impairment patients<br>|
| Experimental: Moderate hepatic Impairment<br>Moderate Hepatic Impairment Patients | Drug: Dimebon<br>* Dimebon 5mg in moderate hepatic impairment patients<br>|
| Experimental: Severe Hepatic Impairment<br>Severe Hepatic Impairment Patients | Drug: Dimebon<br>* Dimebon 5mg in Severe Hepatic Impairment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC and Cmax) |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (AEs, labs, ECG, vitals) |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dimebon Hepatic Impairment