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

Sponsor:	Pfizer
Collaborator:	Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00988624

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 I

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:

Genetics Home Reference related topics: Alzheimer disease chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Alzheimer's Disease Huntington's Disease

Drug Information available for: Dimebolin

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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 February 09, 2012