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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Failure

Treatments: Drug: Dimebon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00831532

B1451018

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 4 patient groups

Normal

Experimental group

Description:

Healthy Volunteers

Treatment:

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Mild Hepatic Impairment

Experimental group

Description:

Mild hepatic impairment patients

Treatment:

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Moderate hepatic Impairment

Experimental group

Description:

Moderate Hepatic Impairment Patients

Treatment:

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Severe Hepatic Impairment

Experimental group

Description:

Severe Hepatic Impairment Patients

Treatment:

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon

Drug: Dimebon