NCT00814931

Examining the Effects of CXB722 in Neuroendocrine Stress Response in Healthy Males

A Phase 1, Multiple Dose, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Examining the Effects of CXB722 in Mitigating Neuroendocrine Stress Response in Healthy Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: CeNeRx BioPharma Inc. · Industry
• Sex: Male
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effects of CXB722 on neuroendocrine stress response and subjective reports related to mood and stress during and after experimentally induced stress among healthy young males.

Detailed description

Acute stress produces a cascade of physiological and psychological effects, including increased cardiovascular function, increases in circulating levels of stress hormones and neurotransmitter levels, and changes in mood and subjective state. The Trier Social Stress Test (TSST) is a standardized, well-validated procedure that was developed in order to provide a controlled method for exposing subjects to a stressor. The TSST consists of a public speaking and a mental arithmetic test performed in the context of a mock job interview. A drug that could safely block or mitigate the stress response would have multiple applications in medicine, beyond treating anxiety, because stress is associated with many disease states, including cardiovascular disease. The drug being studied, CXB722, is thought to show promise in diminishing the physiologic and psychological effects of stress.

Conditions

• Stress
• Anxiety

Interventions

Type	Name	Description
DRUG	CXB722	900 mg CXB722 oral liquid suspension twice a day for 8 days
DRUG	Placebo	matching oral liquid suspension placebo twice a day for 8 days

Timeline

• Start date: 2008-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-12-25
• Last updated: 2009-01-13

Locations

1 site across 1 country: United States