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

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00907322
First received: May 20, 2009
Last updated: July 20, 2009
Last verified: July 2009

May 20, 2009
July 20, 2009
June 2009
July 2009   (final data collection date for primary outcome measure)
  • Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring. [ Time Frame: July 2009 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F. [ Time Frame: July 2009 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00907322 on ClinicalTrials.gov Archive Site
Pharmacodynamics: results of a Drug Effect Questionnaire [ Time Frame: once each arm ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Healthy Volunteers
  • 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
    Intervention: Drug: Dimebon
  • Experimental: Dimebon 40 mg
    Intervention: Drug: Dimebon
  • Experimental: Dimebon 60 mg
    Intervention: Drug: Dimebon
  • Experimental: Placebo
    Intervention: Drug: Dimebon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2009
July 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00907322
B1451036
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

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