Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
NCT00831532
ABOUT THIS STUDY
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- 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.
- 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).
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Descriptive Information | ||||
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Brief Title ICMJE | Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function | |||
Official Title ICMJE | 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 | |||
Brief Summary |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hepatic Failure | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 23 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00831532 | |||
Other Study ID Numbers ICMJE | B1451018 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Medivation, Inc. | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |