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NCT00808119 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by RTI International.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00808119 is a Phase 1 study that has completed, run by RTI International. The registered enrollment target is 30 participants.

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The verdict

NCT00808119, a Phase 1 study, has completed, sponsored by RTI International.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

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.

Interventions

  • DRUG RTI-336 (CTDP 31862)

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2008-10
Est. Completion 2009-03
Phase Phase 1

Sponsor

RTI International

45 total trials

What the Registry Record Tells You About NCT00808119

The ClinicalTrials.gov registry entry for NCT00808119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI International, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which RTI-336 (CTDP 31862) is the first listed.

NCT00808119 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00808119 about?

NCT00808119 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of RTI-336 in Healthy, Male Subjects". 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,...

What is the current status of trial NCT00808119?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-10. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00808119?

The interventions under investigation include: RTI-336 (CTDP 31862) (DRUG).

Who is sponsoring clinical trial NCT00808119?

This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.