A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)

Last updated: January 11, 2010
Sponsor: Pfizer
Overall Status: Completed

Phase

1

Condition

Alzheimer's Disease

Memory Loss

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT00988624
B1451023
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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. The results of this study will help inform and guide further formulation development efforts with the ultimate goal of reducing dose frequency to once-a-day or twice-a-day.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, orallergic 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 theduration of the study.

  • Pregnant or nursing females; females of childbearing potential who are unwilling orunable to use an acceptable method of non-hormonal contraception.

Study Design

Total Participants: 20
Study Start date:
October 01, 2009
Estimated Completion Date:
December 31, 2009

Connect with a study center

  • Pfizer Investigational Site

    New Haven, Connecticut 06511
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.