Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 1 study, sponsored by RTI International.

NCT00808119 is a Phase 1 study that has completed, run by RTI International. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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
RTI International

45 total trials

What the finished NCT00808119 record still lists

NCT00808119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

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

NCT00808119 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00808119's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00977977 · 30 participants · Phase 2

    Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy

  • NCT01459107 · 30 participants · Phase 2

    Human Upper Extremity Allotransplantation

  • NCT01666080 · 30 participants · NA

    Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

  • NCT01720836 · 30 participants · Phase 1

    Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00808119, the US trial registry maintained by the National Library of Medicine. NCT00808119 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.