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

NCT00831532 | Completed Phase 1

• 1 other identifier: B1451018
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hepatic Failure

Keywords

Dimebon Hepatic Impairment

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (AUC and Cmax)

  1 day

Secondary Outcomes (1)

• Safety (AEs, labs, ECG, vitals)

  1 day

Study Arms (4)

Normal

EXPERIMENTAL

Healthy Volunteers

Drug: Dimebon

Mild Hepatic Impairment

EXPERIMENTAL

Mild hepatic impairment patients

Drug: Dimebon

Moderate hepatic Impairment

EXPERIMENTAL

Moderate Hepatic Impairment Patients

Drug: Dimebon

Severe Hepatic Impairment

EXPERIMENTAL

Severe Hepatic Impairment Patients

Drug: Dimebon

Interventions

Dimebon DRUG

Dimebon 5mg in healthy controls

Normal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead
• Medivation, Inc.: collaborator

Study Sites (2)

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46260, United States

Location

Related Links

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

MeSH Terms

Conditions

Liver Failure

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 29, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

US (2)