A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Dimebon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00907322

B1451036

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Dimebon following single ascending doses. A formal single ascending dose study of this nature has not been performed to date in the Dimebon development program.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
Subjects who display the CYP2D6 extensive, intermediate, ultra-rapid, or poor metabolizer statuses.

Exclusion criteria

A known history of hypersensitivity or previous intolerance to Dimebon or other antihistamines.
Subjects with any previous history of seizures, convulsions, epilepsy, or significant head injury.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).