A double-blind, randomized, placebo controlled, single oral dose, two way cross-over trial to investigate the effects of an orally administered 5-HTP challenge test on hypothalamic fMRS activation in healthy male volunteers. - The effect of a 5-HTP challenge test on hypothalamic fMRS activation.

Centre for Human Drug Research0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•- Age of 18-45 years (extremes included);
•- Able and willing to sign the Informed Consent Form prior to screening evaluations;
•- Able to refrain from use of all (methyl)xanthines (e.g. coffee, tea, cola, chocolate) during each stay at the CHDR clinic;
•- Able to refrain from smoking for the duration of every stay at the CHDR clinic;
•- Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic;
•- Able to refrain from strenuous physical exercise from 48 hours prior to each dosing until dismissal from the CHDR clinic;
•- No disturbed day/night rhythm due to e.g. working in night-shifts or traveling over time zones within 3 weeks prior to the first dose;
•- Use of no prescribed drug (especially psychotropic drugs) within two weeks preceding the first dose, excluding paracetamol and certain dermatological preparations (as to judgement of research physician);
•- Using a current daily average of a maximum of 4 Units alcohol;
•- Using a current daily average of a maximum of 4 Units (methyl)xanthines (e.g. coffee, tea, cola, chocolate);
•- Smoking a maximum of 5 cigarettes per day;
•- No past or present recreational use of methamphetamines, MDMA or *ecstasy*;
•- No history of drug sensitivity.

•- A body mass index (BMI) of <18 or >28 kg/m2 (extremes included);
•- Cardiac pacemaker, implants not approved for ultra-high field MRI, piercing or other metal objects attached to the body that cannot be removed (dental fillings are allowed);
•- (History of) claustrophobia;
•- (History of) physical illness as determined by history taking, physical and laboratory examinations, ECG and vital signs recordings;
•- Clinically significant pulmonary, cardiac, renal, hepatic, neurological (including epilepsy), endocrinological or gastrointestinal disease;
•- Past or present clinically significant DSM-IV psychiatric disorder and/or substance abuse disorder, as diagnosed by GP or psychiatrist;
•- Parents, children or siblings with a clinically significant psychiatric disease as diagnosed by GP or psychiatrist;
•- Use of illicit drugs within two weeks prior to screening;
•- Positive drug screen (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or alcohol screen at screening and/or admission;
•- Blood donation within 90 days prior to the first dose;
•- Participation in an investigational drug study within 90 days prior to the first dose, or in four studies (or more) in the past year;
•- Positive test result on hepatitis B surface antigen or hepatitis C antibodies;
•- Positive test result on HIV 1/2 serology.

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