MedTrace Logo

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

NCT01633437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-07-04

No results posted yet for this 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

Interventions

DRUG

CX157

CX157 Modified Release Tablet 125 mg administered twice per day on study days 4-11 and in the morning of study day 12.

OTHER

Placebo

Placebo administered twice per day on study days 4-11 and in the morning of day 12.

Sponsors & Collaborators

  • CeNeRx BioPharma Inc.

    lead INDUSTRY

Principal Investigators

  • William Gerson, D.O. · Comprehensive Phase One

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633437 on ClinicalTrials.gov