Trial record 17 of 21 for:    Dimebon Alzheimer's

A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00825084
First received: January 12, 2009
Last updated: April 22, 2011
Last verified: April 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 45
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single dose cohort-Japanese group
Japanese healthy subjects
Drug: Dimebon
dose escalation of single oral doses of 5, 10 and 20 mg
Experimental: single dose cohort-Western group
Western healthy subjects
Drug: Dimebon
dose escalation of single oral doses of 5, 10 and 20 mg
Experimental: multiple dose cohort-Japanese group
Japanese healthy subjects
Drug: Dimebon
10 mg TID of Dimebon for 7 days followed by 20 mg TID of Dimebon for 7 days
Experimental: multiple dose cohort-Western group
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
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: NCT00825084

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
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: NCT00825084     History of Changes
Other Study ID Numbers: B1451014
Study First Received: January 12, 2009
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Dimebon, Japanese and Western population, pharmacokinetics

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 October 01, 2014