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

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.

Timeline

Start

2008-10

Primary completion

2009-03

Completion

2009-03

Publications

• Carroll FI, Kosten TR, Buda JJ, Wang L, Walters BB. A Double-Blind, Placebo-Controlled Trial Demonstrating the Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of RTI-336. Front Pharmacol. 2018 Jul 10;9:712. doi: 10.3389/fphar.2018.00712. eCollection 2018.

Drugs

Indications