A double blind, single dose, randomized, 2-way crossover, placebo controlled study to set-up the resting state test in 10 healthy subjects - ND

• Conditions: A, Set-up model study

• Registration Number: EUCTR2009-013069-24-IT
• Lead Sponsor: AZIENDA OSPEDALIERA - CENTRO RICERCHE CLINICHE DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Healthy, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator determines that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 2. Male and female aged 18 to 50 years inclusive at the screening visit. 3. Body weight ≥ 50 kg and BMI within the range of 19-29 kg/m2, inclusive. 4. Absence of any mental illness.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. 2. A positive history pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. 3. QTc interval >450 ms, and/or a PR interval outside the range 120 to 200 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave). 4. The subject has a sustained resting pulse rate <40 or >100 bpm OR a systolic blood pressure >140 or <90 OR a diastolic blood pressure >90 or <50. 5. The subject has a significant cardiac disease or cardiac conduction disorder. 6. Consumption of poppy-seed-containing food, or any other food or drink containing quinine, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices], red wine, Seville oranges, apple juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) from 7 days prior to the first dose of study medication until the last dose. 7. During each dosing session, subjects will not abstain from ingesting caffeine- or xanthine-containing products (e.g. coffee, tea, cola drinks, chocolate) for 24 hours prior to and after dosing during each session. 8. During each dosing session, subjects will not abstain from alcohol for 24 hours prior to dosing until discharge from the Unit. 9. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine. 10. The subject has participated in a clinical trial and has received an investigational product within 6 month period prior to the first dosing day in the current study. 11. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until the discharge at the second study occasion, unless in the opinion of the Investigator the medication will not interfere with the study. 12. History of sensitivity to any of the study medications or components thereof, or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation. 13. A female childbearing potential, defined as: - Subjects not postmenopausal (defined as 12 months of spontaneous amenorrhea) who not using the contraception methods or stopping their oral contraceptive during the study or without a documented tubal ligation or hysterectomy. - An unwillingness of pre-menopausal female subject to use contraception methods. 14. Unwillingness or inability to follow the procedures outlined in the protocol. 15. History of or suffers from claustrophobia or feels that they will be unable to lie in the MRI. 16. History or presence of neurological or psychiatric conditions (e.g., stroke, significant traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson`s disease, vascular dementia, transient ischemic attack, any unexplained loss of consciousness, schizophrenia, major depression

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the reproducibility of the resting state test.;Secondary Objective: To explore the effects of a single dose of Alprazolam on brain activity in resting state step to explore the effects of a single dose of Alprazolam on brain activity in motor task step.;Primary end point(s): Brain resting-state functional-connectivity at baseline in two different occasions.