Trial record 13 of 21 for:    Dimebon Alzheimer's

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

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00988624
First received: October 1, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Huntington Disease
Drug: Dimebon IR Tablet
Drug: Dimebon MR1
Drug: Dimebon MR2
Drug: Dimebon MR3
Drug: Dimebon MR4
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1 Drug: Dimebon IR Tablet
Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.
Experimental: Period 2 Drug: Dimebon MR1
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.
Experimental: Period 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.
Experimental: Period 4 Drug: Dimebon MR3
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.
Experimental: Period 5 Drug: Dimebon MR4
Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988624

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00988624     History of Changes
Other Study ID Numbers: B1451023
Study First Received: October 1, 2009
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
bioavailability pharmacokinetics Alzheimer's Disease Huntington Disease

Additional relevant MeSH terms:
Alzheimer Disease
Huntington Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Cognition Disorders

ClinicalTrials.gov processed this record on July 31, 2014