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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: Completed Phase 1 study of Major Depressive Disorder, sponsored by CeNeRx BioPharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SBP was measured every 5 minutes for the first two hours and every 15 minutes for the next two hours post tyramine ingestion on study Days 10 (20 mg tyramine), 11 (40 mg tyramine), and 12 (80 mg tyramine).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CX157
Study Locations (1)
Florida
- Comprehensive Phase One - Miramar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-09 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT01633437 record still lists
NCT01633437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01633437's enrollment target sits among peer trials
12 265th of 282 higher than 15 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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
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