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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

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 22, 2009
Last Update Posted Date July 22, 2009
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring. [ Time Frame: July 2009 ]
  • Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F. [ Time Frame: July 2009 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Pharmacodynamics: results of a Drug Effect Questionnaire [ Time Frame: once each arm ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Dimbeon 20 mg
    Intervention: Drug: Dimebon
  • Experimental: Dimebon 40 mg
    Intervention: Drug: Dimebon
  • Experimental: Dimebon 60 mg
    Intervention: Drug: Dimebon
  • Experimental: Placebo
    Intervention: Drug: Dimebon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907322
Other Study ID Numbers  ICMJE B1451036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP