A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects
NCT00825084
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 45 | |||
Original Estimated Enrollment ICMJE | 48 | |||
Actual Study Completion Date ICMJE | May 2009 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00825084 | |||
Other Study ID Numbers ICMJE | B1451014 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Medivation, Inc. | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |