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Completed

NCT Number: NCT00831532

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dimebon

Drug

Dimebon 5mg in healthy controls

Primary outcomes

  1. Pharmacokinetics (AUC and Cmax)

    Time frame: 1 day

Secondary outcomes

  1. Safety (AEs, labs, ECG, vitals)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Medivation, Inc.

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2009
Registry last updated
Sep 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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