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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Failure
• Intervention / Treatment: Drug: Dimebon; Drug: Dimebon; Drug: Dimebon; Drug: Dimebon

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normal; Healthy Volunteers	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
EXPERIMENTAL: Mild Hepatic Impairment; Mild hepatic impairment patients	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
EXPERIMENTAL: Moderate hepatic Impairment; Moderate Hepatic Impairment Patients	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
EXPERIMENTAL: Severe Hepatic Impairment; Severe Hepatic Impairment Patients	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Medivation, Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 28, 2009
• First Posted (ESTIMATE): January 29, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 16, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Dimebon Hepatic Impairment
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: B1451018