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

Hepatic Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831532
• Other study ID #: B1451018
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2009
• Last updated: September 14, 2009
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Failure
• Liver Diseases
• Liver Failure

Intervention

Drug:
• Dimebon
Dimebon 5mg in healthy controls
• Dimebon
Dimebon 5mg in mild hepatic impairment patients
• Dimebon
Dimebon 5mg in moderate hepatic impairment patients
• Dimebon
Dimebon 5mg in Severe Hepatic Impairment

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (AUC and Cmax)		1 day	No
Secondary	Safety (AEs, labs, ECG, vitals)		1 day	Yes

External Links

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