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:
Pfizer
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
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Purpose
- To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function.
- To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function.
- 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
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
Keywords provided by Pfizer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
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 Failure Liver Diseases Hepatic Insufficiency Digestive System Diseases |
ClinicalTrials.gov processed this record on October 18, 2012