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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988624
First Posted: October 2, 2009
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
October 1, 2009
October 2, 2009
January 12, 2010
October 2009
December 2009   (Final data collection date for primary outcome measure)
PK endpoints for dimebon and M7 (where appropriate) for each formulation: AUC0-24, AUC0-24(dn), AUCinf (as data permit) AUCinf(dn), AUClast, AUClast(dn), Tlag, Cmax, Tmax, and t1/2 (as data permit). [ Time Frame: Day 1-3 of Period 1, 2, 3, 4, or 5 ]
Same as current
Complete list of historical versions of study NCT00988624 on ClinicalTrials.gov Archive Site
Safety and tolerability for each formulation (AEs, ECG, vital signs, safety labs) [ Time Frame: Day 1-3 of Period 1, 2, 3, 4, or 5 ]
Same as current
Not Provided
Not Provided
 
A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Alzheimer's Disease
  • Huntington Disease
  • Drug: Dimebon IR Tablet
    Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
  • Drug: Dimebon MR1
    Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
  • Drug: Dimebon MR2
    Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.
  • Drug: Dimebon MR3
    Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
  • Drug: Dimebon MR4
    Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.
  • Experimental: Period 1
    Intervention: Drug: Dimebon IR Tablet
  • Experimental: Period 2
    Intervention: Drug: Dimebon MR1
  • Experimental: Period 3
    Intervention: Drug: Dimebon MR2
  • Experimental: Period 4
    Intervention: Drug: Dimebon MR3
  • Experimental: Period 5
    Intervention: Drug: Dimebon MR4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
December 2009   (Final data collection date for primary outcome measure)

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 Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00988624
B1451023
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP