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A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults

NCT ID: NCT00907322

Last Updated: 2009-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Dimebon following single ascending doses. A formal single ascending dose study of this nature has not been performed to date in the Dimebon development program.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dimbeon 20 mg

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Oral tablet; 20 mg Dimebon, single dose

Dimebon 40 mg

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Oral tablet; 40 mg Dimebon, single dose

Dimebon 60 mg

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Oral tablet; 60 mg Dimebon, single dose

Placebo

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Oral tablet; placebo, single dose

Interventions

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Dimebon

Oral tablet; 20 mg Dimebon, single dose

Intervention Type DRUG

Dimebon

Oral tablet; 40 mg Dimebon, single dose

Intervention Type DRUG

Dimebon

Oral tablet; 60 mg Dimebon, single dose

Intervention Type DRUG

Dimebon

Oral tablet; placebo, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Subjects who display the CYP2D6 extensive, intermediate, ultra-rapid, or poor metabolizer statuses.

Exclusion Criteria

* A known history of hypersensitivity or previous intolerance to Dimebon or other antihistamines.
* Subjects with any previous history of seizures, convulsions, epilepsy, or significant head injury.
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medivation, Inc.

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451036&StudyName=A%20Phase%201%20Trial%20To%20Assess%20The%20Safety%20And%20Pharmacokinetics%20Of%20Single%2C%20Ascending%2C%20Oral%20Doses%20Of%20Dimebon%20In%20Healthy%20Adults

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1451036

Identifier Type: -

Identifier Source: org_study_id

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