A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects - Full Text View

Sponsors and Collaborators:	Pfizer Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00825084

Purpose

This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The secondary objective of this study is to compare the pharmacokinetics, safety and tolerability of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.

Condition	Intervention	Phase
Alzheimer's Disease Huntington's Disease	Drug: Dimebon	Phase I

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 Hurricanes

Drug Information available for: Dimebolin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Pharmacokinetics Study
Official Title:	A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:

plasma drug concentrations [ Time Frame: 72 hours post last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety will be including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring [ Time Frame: 72 hours post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	February 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single dose cohort-Japanese group: Experimental Japanese healthy subjects	Drug: Dimebon dose escalation of single oral doses of 5, 10 and 20 mg
single dose cohort-Western group: Experimental Western healthy subjects	Drug: Dimebon dose escalation of single oral doses of 5, 10 and 20 mg
multiple dose cohort-Japanese group: Experimental Japanese healthy subjects	Drug: Dimebon 10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
multiple dose cohort-Western group: Experimental Western healthy subjects	Drug: Dimebon 10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days

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 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight within the range of 50 to 100 kg.
An informed consent document signed and dated by the subject or a legally-acceptable representative.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Japanese subjects must have four Japanese grandparents who were born in Japan.

Exclusion Criteria:

Asian or Polynesian subjects in Western subject groups.
Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
History of regular alcohol consumption exceeding an average of 7 drinks/week for females and 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
Subjects who, by history, smoke more than 5 cigarettes per day.
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG may be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
Use of prescription or nonprescription drugs, vitamins and dietary supplements, within 7 days or 5 half-lives (whichever is longer) of the first dose of study medication. Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤ 2 grams/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825084

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, California
Pfizer Investigational Site	Recruiting
Glendale, California, United States, 91206

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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1451014
Study First Received:	January 12, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00825084 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Dimebon, Japanese and Western population, pharmacokinetics

Study placed in the following topic categories:

Ganglion Cysts
Alzheimer Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Healthy
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders

Chorea
Heredodegenerative Disorders, Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Dementia
Huntington Disease
Delirium

Additional relevant MeSH terms:

Alzheimer Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea

Heredodegenerative Disorders, Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Dementia
Tauopathies
Huntington Disease

ClinicalTrials.gov processed this record on May 07, 2009