Examining the Effects of CXB722 in Neuroendocrine Stress Response in Healthy Males (CXB722-100)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00814931
First received: December 23, 2008
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Stress
Anxiety
Drug: CXB722
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Plasma cortisol and salivary cortisol levels [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma ACTH [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]
  • Plasma epinephrine and norepinephrine [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]
  • Profile of Mood States (POMS) Tension-Anxiety [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]
  • Fatigue-Inertia, and Vigor-Activity factor scores [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]
  • "State" score on the Spielberger State-Trait Anxiety Scale (SSTAS) [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]
  • Seven Visual Analog Scales (VAS) [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: No ]
  • HR, and systolic and diastolic BP [ Time Frame: Screening and Study Day 8 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: December 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment Group
Drug: CXB722
900 mg CXB722 oral liquid suspension twice a day for 8 days
Other Name: Pivagabine
Placebo Comparator: 2 Drug: Placebo
matching oral liquid suspension placebo twice a day for 8 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, 18 to 34 years of age, inclusive, at screening
  • Able to read, understand and converse in English
  • Able to read, understand, and provide written, dated informed consent
  • Willing to refrain from the use of any concomitant medications (including over-the counter (OTC)) and nutritional/herbal supplements and comply with all study requirements
  • Willing to submit to daily breathalyzer testing each day study medication is administered over the course of the study
  • In good general health as ascertained by medical history, physical examination (PE) including measurement of vital signs, clinical laboratory evaluations, and 12-lead electrocardiogram (ECG)

Exclusion Criteria:

  • Evidence on physical examination or laboratory findings of chronic liver or renal disease or other chronic physical disorders
  • Evidence of cardiovascular disease on 12 lead ECG, vital signs or laboratory findings
  • Significant anxiety as indicated by a score of 47 or higher on the "Trait" score of Spielberger State-Trait Anxiety Scale
  • Family history (first degree relative) of hypertension or cardiovascular disease prior to age 40
  • Evidence on physical or laboratory examination of endocrinopathies or immunopathies, including HIV
  • BMI of 30 or greater, evidence of significant recent weight change or history of obesity
  • History of any psychiatric disorder, or evidence of such a disorder based on a psychiatric evaluation which includes the Structured Clinical Interview for DSM-IV-TR (SCID)
  • History of any physical condition which, in the investigator's opinion, might put the participant at risk or interfere with the interpretation of study results
  • Use of any prescription or over-the-counter (OTC) medications (including herbal remedies) within 14 days of study randomization
  • Use of tobacco products or any nicotine-containing products (e.g., gum, patch) within the past 6 months (prior to screening)
  • Positive screening urine test for nicotine or drugs of abuse: cannabinoids, cocaine, amphetamines, barbiturates, opiates, benzodiazepines, or alcohol in the blood
  • Unwillingness to agree to avoid strenuous activity over the course of the study
  • Poor likelihood, in the investigator's judgment, of full cooperation during the study and/or poor compliance is anticipated
  • Previously screened for this trial
  • Consumes more than four cups of coffee daily
  • Deviates from normal nocturnal sleeping patterns
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814931

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
CeNeRx BioPharma Inc.
Investigators
Principal Investigator: Carlos Santana, MD USF Physicians Group, Associate Professor, Director of Adult Outpatient Services, Department of Psychiatry and Behavioral Medicine
  More Information

Publications:
Responsible Party: Carlos Santana, MD, USF Physicians Group
ClinicalTrials.gov Identifier: NCT00814931     History of Changes
Other Study ID Numbers: AG0114
Study First Received: December 23, 2008
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014