A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users - Full Text View

Sponsor:	Pfizer
Collaborator:	Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00975481

Purpose

Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).

Condition	Intervention	Phase
Alzheimer's Disease Huntington's Disease	Drug: dimebon Drug: placebo Drug: alprazolam	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomized, Double-Blind, Placebo- And Active-Controlled Single-Dose, Crossover Study To Evaluate The Abuse Potential Of Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Alzheimer's Disease Huntington's Disease

Drug Information available for: Alprazolam Dimebolin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Balance of Effects: • Drug Liking VAS maximum (Emax) and minimum (Emin) effect. • Overall Drug Liking VAS Emax and Emin. • Take Drug Again VAS Emax. • Good and Bad Effects VAS Emax and Emin. • SDV Emax. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Positive Effects: • ARCI (MBG) Emax. • Good Drug Effects VAS Emax. • High VAS Emax. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Negative Effects: • Bad Drug Effects VAS Emax. • ARCI (LSD) Emax. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Sedative Effects: • ARCI (PCAG) Emax. • Alertness/Drowsiness VAS Emin. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Other Subjective Effects: • Any Drug Effects VAS Emax. • Drug Similarity VAS (mean scores). • ARCI (BG) Emax and Emin. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring. [ Time Frame: Day 1, Follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
dimebon 20 mg: Experimental	Drug: dimebon Oral tablet; 20 mg dimebon, single dose
dimebon 40 mg: Experimental	Drug: dimebon Oral tablet; 40 mg dimebon, single dose
dimebon 60 mg: Experimental	Drug: dimebon Oral tablet; 60 mg dimebon, single dose
placebo: Placebo Comparator	Drug: placebo Oral tablet or capsule; placebo, single dose
alprazolam 1 mg: Active Comparator	Drug: alprazolam Oral capsule; 1 mg alprazolam, single dose
alprazolam 3 mg: Active Comparator	Drug: alprazolam Oral capsule; 3 mg alprazolam, single dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years.
Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975481

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Canada, Ontario
Pfizer Investigational Site	Recruiting
Toronto, Ontario, Canada, M5V 2T3

Sponsors and Collaborators

Pfizer

Medivation, Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1451037
Study First Received:	September 10, 2009
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00975481 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Pfizer:

oral single-dose 6-way crossover recreational drug users abuse potential pharmacodynamics safety

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Basal Ganglia Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Neurodegenerative Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Therapeutic Uses
Hypnotics and Sedatives
Dementia
Tranquilizing Agents

Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Central Nervous System Depressants
Dyskinesias
Cognition Disorders
Pharmacologic Actions
Chorea
Delirium, Dementia, Amnestic, Cognitive Disorders
Alprazolam
Genetic Diseases, Inborn
GABA Agents
Anti-Anxiety Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010