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

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00831532
First received: January 20, 2009
Last updated: September 14, 2009
Last verified: September 2009
  Purpose
  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.

Condition Intervention Phase
Hepatic Failure
Drug: Dimebon
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics (AUC and Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (AEs, labs, ECG, vitals) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal
Healthy Volunteers
Drug: Dimebon
Dimebon 5mg in healthy controls
Experimental: Mild Hepatic Impairment
Mild hepatic impairment patients
Drug: Dimebon
Dimebon 5mg in mild hepatic impairment patients
Experimental: Moderate hepatic Impairment
Moderate Hepatic Impairment Patients
Drug: Dimebon
Dimebon 5mg in moderate hepatic impairment patients
Experimental: Severe Hepatic Impairment
Severe Hepatic Impairment Patients
Drug: Dimebon
Dimebon 5mg in Severe Hepatic Impairment

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831532

Locations
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00831532     History of Changes
Other Study ID Numbers: B1451018
Study First Received: January 20, 2009
Last Updated: September 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Dimebon Hepatic Impairment

Additional relevant MeSH terms:
Liver Diseases
Liver Failure
Digestive System Diseases
Hepatic Insufficiency

ClinicalTrials.gov processed this record on October 30, 2014