We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00831532
First Posted: January 29, 2009
Last Update Posted: September 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Safety (AEs, labs, ECG, vitals) [ Time Frame: 1 day ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00831532     History of Changes
Other Study ID Numbers: B1451018
First Submitted: January 20, 2009
First Posted: January 29, 2009
Last Update Posted: September 16, 2009
Last Verified: September 2009

Keywords provided by Pfizer:
Dimebon Hepatic Impairment

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