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

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ClinicalTrials.gov Identifier: NCT00907322
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : July 22, 2009
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Dimebon Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

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



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

Secondary Outcome Measures :
  1. Pharmacodynamics: results of a Drug Effect Questionnaire [ Time Frame: once each arm ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907322


Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00907322     History of Changes
Other Study ID Numbers: B1451036
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: July 22, 2009
Last Verified: July 2009

Keywords provided by Pfizer:
oral, single ascending doses; CYP2D6 metabolizer status; healthy subjects; safety, tolerability, pharmacokinetics