You are here

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

Last updated on March 14, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now