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

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

Tracking Information

• First Submitted Date: May 20, 2009
• First Posted Date: May 22, 2009
• Last Update Posted Date: July 22, 2009
• Study Start Date: June 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: May 21, 2009): Pharmacodynamics: results of a Drug Effect Questionnaire [ Time Frame: once each arm ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Healthy Volunteers

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 21, 2009): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT00907322
• Other Study ID Numbers: B1451036
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Medivation, Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2009