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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Dimebon

• Registration Number: NCT00907322
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Study Start: 2009-06
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-20
• Last Update Posted: 2009-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dimebon 60 mg	Dimebon	-
Placebo	Dimebon	-
Dimebon 40 mg	Dimebon	-
Dimbeon 20 mg	Dimebon	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacodynamics: results of a Drug Effect Questionnaire	once each arm

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium