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NCT01633437 · ClinicalTrials.gov registry record · Phase 1

Oral Tyramine Pressor Response Study of CX157 Tablets in Healthy Male Volunteers

A Phase 1 study of Major Depressive Disorder, sponsored by CeNeRx BioPharma.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT01633437 is a Phase 1 study of Major Depressive Disorder that has completed, run by CeNeRx BioPharma. The registered enrollment target is 12 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01633437, a Phase 1 study of Major Depressive Disorder, has completed, sponsored by CeNeRx BioPharma.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg administered twice per day (BID) in healthy volunteers compared to placebo; and to investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at steady state compared to placebo.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG CX157

Study Locations (1)

Florida

  • Comprehensive Phase One - Miramar

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-09
Est. Completion 2010-10
Phase Phase 1

Sponsor

CeNeRx BioPharma

4 total trials

What the Registry Record Tells You About NCT01633437

The ClinicalTrials.gov registry entry for NCT01633437 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower). The listed sponsor is CeNeRx BioPharma, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01633437 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01633437 about?

NCT01633437 is a clinical study titled "Oral Tyramine Pressor Response Study of CX157 Tablets in Healthy Male Volunteers". The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg administered twice per day (BID) in healthy volunteers compared to placebo; and to investigate the general safety, tolerab...

What is the current status of trial NCT01633437?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-09. Estimated completion is 2010-10.

What conditions does trial NCT01633437 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT01633437?

The interventions under investigation include: Placebo (OTHER), CX157 (DRUG).

Who is sponsoring clinical trial NCT01633437?

This trial is sponsored by CeNeRx BioPharma, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01633437 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.