- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00814931
Examining the Effects of CXB722 in Neuroendocrine Stress Response in Healthy Males (CXB722-100)
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
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
-
-
Florida
-
Tampa, Florida, Spojené státy, 33612
- University of South Florida
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: 2
|
matching oral liquid suspension placebo twice a day for 8 days
|
Experimentální: 1
Léčebná skupina
|
900 mg CXB722 oral liquid suspension twice a day for 8 days
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Plasma cortisol and salivary cortisol levels
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Plasma ACTH
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
Plasma epinephrine and norepinephrine
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
Profile of Mood States (POMS) Tension-Anxiety
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
Fatigue-Inertia, and Vigor-Activity factor scores
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
"State" score on the Spielberger State-Trait Anxiety Scale (SSTAS)
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
Seven Visual Analog Scales (VAS)
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
HR, and systolic and diastolic BP
Časové okno: Screening and Study Day 8
|
Screening and Study Day 8
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Carlos Santana, MD, USF Physicians Group, Associate Professor, Director of Adult Outpatient Services, Department of Psychiatry and Behavioral Medicine
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- AG0114
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Stres
-
VA Office of Research and DevelopmentVA St. Louis Health Care SystemUkončenoVeteráni podle St. Louis VAMC Stress TesSpojené státy