NCT00907322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 22, 2009

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

May 20, 2009

Last Update Submit

July 20, 2009

Conditions

Healthy Volunteers

Keywords

oral, single ascending doses; CYP2D6 metabolizer status; healthy subjects; safety, tolerability, pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring.

    July 2009

  • Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F.

    July 2009

Secondary Outcomes (1)

  • Pharmacodynamics: results of a Drug Effect Questionnaire

    once each arm

Study Arms (4)

Dimbeon 20 mg

EXPERIMENTAL
Drug: Dimebon

Dimebon 40 mg

EXPERIMENTAL
Drug: Dimebon

Dimebon 60 mg

EXPERIMENTAL
Drug: Dimebon

Placebo

EXPERIMENTAL
Drug: Dimebon

Interventions

DimebonDRUG

Oral tablet; 20 mg Dimebon, single dose

Dimbeon 20 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Interventions

latrepirdine

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 22, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 22, 2009

Record last verified: 2009-07

Locations

BE(1)