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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
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Dimebon
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Pharmacodynamics: results of a Drug Effect Questionnaire [ Time Frame: once each arm ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907322

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00907322     History of Changes
Other Study ID Numbers: B1451036
Study First Received: May 20, 2009
Last Updated: July 20, 2009
Health Authority: Belgium: European Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014