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

NCT00814931 | Completed Phase 1

• 1 other identifier: AG0114
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress; Anxiety

Outcome Measures

Primary Outcomes (1)

• Plasma cortisol and salivary cortisol levels

  Screening and Study Day 8

Secondary Outcomes (7)

• Plasma ACTH

  Screening and Study Day 8

• Plasma epinephrine and norepinephrine

  Screening and Study Day 8

• Profile of Mood States (POMS) Tension-Anxiety

  Screening and Study Day 8

• Fatigue-Inertia, and Vigor-Activity factor scores

  Screening and Study Day 8

• "State" score on the Spielberger State-Trait Anxiety Scale (SSTAS)

  Screening and Study Day 8

Study Arms (2)

1

EXPERIMENTAL

Treatment Group

Drug: CXB722

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CXB722 DRUG

900 mg CXB722 oral liquid suspension twice a day for 8 days

Also known as: Pivagabine

1

Placebo DRUG

matching oral liquid suspension placebo twice a day for 8 days

2

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• CeNeRx BioPharma Inc.: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.

  PMID: 8255414 BACKGROUND

• Kirschbaum C, Strasburger CJ, Langkrar J. Attenuated cortisol response to psychological stress but not to CRH or ergometry in young habitual smokers. Pharmacol Biochem Behav. 1993 Mar;44(3):527-31. doi: 10.1016/0091-3057(93)90162-m.

  PMID: 8451256 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

pivagabine

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Carlos Santana, MD

  USF Physicians Group, Associate Professor, Director of Adult Outpatient Services, Department of Psychiatry and Behavioral Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 13, 2009

Record last verified: 2009-01

Locations

US (1)