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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Orlando, Florida, 32809 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00831532
Pfizer
Completed
Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function

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Descriptive Information
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
  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.
Detailed DescriptionNot 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
  • Drug: Dimebon
    Dimebon 5mg in healthy controls
  • Drug: Dimebon
    Dimebon 5mg in mild hepatic impairment patients
  • Drug: Dimebon
    Dimebon 5mg in moderate hepatic impairment patients
  • Drug: Dimebon
    Dimebon 5mg in Severe Hepatic Impairment
Study Arms  ICMJE
  • Experimental: Normal
    Healthy Volunteers
    Intervention: Drug: Dimebon
  • Experimental: Mild Hepatic Impairment
    Mild hepatic impairment patients
    Intervention: Drug: Dimebon
  • Experimental: Moderate hepatic Impairment
    Moderate Hepatic Impairment Patients
    Intervention: Drug: Dimebon
  • Experimental: Severe Hepatic Impairment
    Severe Hepatic Impairment Patients
    Intervention: Drug: Dimebon
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
 (submitted: September 14, 2009)
23
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2009)
24
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion DateAugust 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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