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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
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 ]

Enrollment:	36
Study Start Date:	October 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Detailed Description:

The main purpose for this study is to determine whether dimebon exhibits abuse potential.

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

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00975481 History of Changes
Other Study ID Numbers:	B1451037
Study First Received:	September 10, 2009
Last Updated:	February 25, 2010
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:

Alzheimer Disease
Huntington Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn
Cognition Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012