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

July 20, 2009 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Dimebon
Oral tablet; 20 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 40 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 60 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; placebo, single dose
Experimental: Dimbeon 20 mg
Drug: Dimebon
Oral tablet; 20 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 40 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 60 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; placebo, single dose
Experimental: Dimebon 40 mg
Drug: Dimebon
Oral tablet; 20 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 40 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 60 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; placebo, single dose
Experimental: Dimebon 60 mg
Drug: Dimebon
Oral tablet; 20 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 40 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; 60 mg Dimebon, single dose
Drug: Dimebon
Oral tablet; placebo, single dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Medivation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 21, 2009

First Posted (Estimate)

May 22, 2009

Study Record Updates

Last Update Posted (Estimate)

July 22, 2009

Last Update Submitted That Met QC Criteria

July 20, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B1451036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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