Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of RTI-336 in Healthy, Male Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00808119|
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : July 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: RTI-336 (CTDP 31862)||Phase 1|
Cocaine abuse has been an epidemic in the United States since the mid- to late-1970s. It is hypothesized that a medication to treat cocaine addiction should have some, but not all, of the behavioral pharmacological properties of cocaine. Substantial evidence links the euphoric highs and addictive properties of cocaine to the inhibition of the dopamine transporter (DAT) in the brain. Cocaine binds quickly and potently to this transporter and blocks the presynaptic uptake of dopamine, resulting in subjective highs and reinforcing effects in both preclinical studies and humans. Compounds that mimic the DAT-binding properties of cocaine that are less stimulating and act with a slower receptor onset and offset may prove useful as treatment for cocaine dependence. The 3-phenyltropane analog, RTI-336, is a potent and selective DAT inhibitor that has demonstrated desirable pharmacological properties in preclinical species and is an appropriate compound to test for its potential as a medication to treat cocaine dependence.
This is the first study to be conducted in humans for RTI-336, a new chemical entity, with evaluations focusing on the safety, tolerability, and pharmacokinetics of RTI-336 following administration of single, oral doses, with the possibility of identifying the maximum tolerated dose in humans. Data from this study will be used to plan for and define dose ranges for subsequent studies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of RTI-336 in Healthy, Male Subjects|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- Drug: RTI-336 (CTDP 31862)
The RTI-336 drug product is formulated as hard, white, gelatin capsules. The dosage levels are 0.3, 1.0, and 3.0 mg (Cohort 1) and 6.0, 12.0, and 20.0 mg (Cohort 2). Subjects will receive a single dose of the study drug on study day 1.
- Safety and tolerability of RTI-336; clinical signs and symptoms, adverse events (AEs), vital signs, electrocardiographic (ECG) parameters, clinical laboratory test results [ Time Frame: Days 0 (Baseline), 1-3, and 8 ]
- Pharmacokinetic parameters of RTI-336 and metabolites [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, and 48 hours after dosing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808119
|United States, Florida|
|Comprehensive Phase One|
|Miramar, Florida, United States, 33025|
|Principal Investigator:||William A. Gerson, DO, CPI||Comprehensive Phase One|