Status:
COMPLETED
A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 per...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00907322
Start Date
June 1 2009
End Date
July 1 2009
Last Update
July 22 2009
Active Locations (1)
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1
Pfizer Investigational Site
Brussels, Belgium, 1070