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

Study Overview
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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.

Official Title
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A Phase 1, Investigator- And Subject-Blind (Sponsor-Open), Randomized, Crossover, Placebo-Controlled Trial To Assess The Safety, Tolerability, And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon [PF-01913539] In Healthy Adult Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Dimebon
* Drug: Dimebon
* Drug: Dimebon
* Drug: Dimebon


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dimbeon 20 mg<br> | Drug: Dimebon<br>* Oral tablet; 20 mg Dimebon, single dose<br>|
| Experimental: Dimebon 40 mg<br> | Drug: Dimebon<br>* Oral tablet; 40 mg Dimebon, single dose<br>|
| Experimental: Dimebon 60 mg<br> | Drug: Dimebon<br>* Oral tablet; 60 mg Dimebon, single dose<br>|
| Experimental: Placebo<br> | Drug: Dimebon<br>* Oral tablet; placebo, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring. |  | July 2009 | 
| Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F. |  | July 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: results of a Drug Effect Questionnaire |  | once each arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral, single ascending doses; CYP2D6 metabolizer status; healthy subjects; safety, tolerability, pharmacokinetics