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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 December 16, 2017

FOR MORE INFORMATION
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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Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
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
  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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatic Failure
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
August 2009
August 2009   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00831532
B1451018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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