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Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of RTI-336 in Healthy, Male Subjects

NCT00808119 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-07-21

No results posted yet for this study

Summary

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. RTI-336 is a novel dopamine transporter inhibitor of the 3-phenyltropane class, and is currently being developed by RTI International as a potential pharmacotherapy to treat cocaine dependence. Data from this study will be used to plan and define dose ranges for subsequent studies.

Conditions

  • Cocaine Dependence

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • RTI International

    lead OTHER

Principal Investigators

  • William A. Gerson, DO, CPI · Comprehensive Phase One

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808119 on ClinicalTrials.gov