Status:
COMPLETED
A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Alzheimer's Disease
Huntington Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate four different modified release formulation to estimate the amount of dimebon available to the body relative to the current dimebon formulation that is given three times a day...
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion
- 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).
- Subjects with any history of a previous seizure (including childhood febrile seizures) or convulsion or significant head trauma.
- Subjects with hypersensitivity reactions to dimebon or other antihistamines.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Smokers who use greater than 5 cigarettes per day.
- Use of proton pump inhibitors, antacids, and H2-blockers are prohibited for the duration of the study.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00988624
Start Date
October 1 2009
End Date
December 1 2009
Last Update
January 12 2010
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511