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:
Pfizer
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 May 19, 2013