anxiety anxiety disorder
Conditions
Interventions
Three ascending single oral doses (i.e. 10, 30, and 50 mg) are planned with a
dose escalation factor of approximately 2. However, based on safety,
pharmacokinetic or pharmacodynamic findings, furthe
Sponsors
Neurosearch
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary provision of written informed consent prior to any study procedure, indicative of understanding the purpose of the study and willing to participate in the study and comply with the study procedures and restrictions. 2. Male. 3. Aged 18-45 years (both inclusive).
Exclusion criteria
Exclusion criteria: 1. Subject is unhealthy according to medical history, physical examination, ECG, blood pressure and heart rate, and laboratory profile of blood and urine. A volunteer with a clinical abnormality may be included only if the investigator or his designee considers that the abnormality will not introduce additional risk factor for the subject's health, or interfere with the study objectives. 2. Presence or history of clinical significant psychiatric diseases, as judged by the investigator. 3. Any clinically relevant acute or chronic diseases which according to the investigator could interfere with the subject*s safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. 4. Presence or history of clinical significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system or presence of history of clinical significant immunological, endocrine, metabolic diseases, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, as judged by the investigator. 5. Presence or history of clinically significant allergy or known hypersensitivity to any component of the investigational product. 6. Has a Body Mass Index (BMI) 30 kg/m2. 7. Has positive serology for HIV-1, HIV-2, hepatitis B (surface antigen), and/or hepatitis C. 8. Has planned medical treatments (including dental care) from screening to follow-up visit. 9. Use of prescribed medication or over-the-counter (OTC) medication within two weeks prior to dosing, except for paracetamol. C HDR Protocol CHDR0907 NS11821 First In Man Study C:\Documents and Settings\Default.WSIMAGE.001\Desktop\CHDR0907_pro_00.doc - 22-06-2009 Page 20 of 142 10. Enrolment in any investigational study or intake of an investigational drug within 3 months prior to the start of the study or more than 4 times a year. 11. Current regular user of any illicit drugs or history of drug or alcohol abuse. Subjects who have a positive drug screen at screening and/or pre-dose or subjects who have a positive alcohol breath test at pre-dose will be excluded. 12. Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines. 13. Previous randomization in this study. 14. Has any barrier (language, mental incapacity, etc.) that could interfere with the psychomotor or cognitive tests. 15. Unlikely to co-operate in the study, and/or has poor compliance anticipated by the investigator. Or not consistently reachable in case of emergency. 16. Daily consumption of xanthine-containing products more than 6 units. Unwilling or unable to refrain from consumption of xanthine-containing foods or drinks from 2 days prior to admission and during the stay in the research unit. One caffeine unit is contained in the following items: one cup of coffee, two cans of cola, one glass of tea, * cup of energy drink (e.g. Red Bull) or three chocolate bars. 17. Unwilling or unable to refrain from intensive physical exercise from screening until the follow-up visit. 18. Unwilling or unable to refrain from products containing alcohol from 2 days before admission and during the stay in the research unit. 19. Unwilling or unable to refrain from products containing grapefruit from 2 days before admission and during the stay in the research unit. 20. Smokes more than 5 cigarettes (or equivalent as judged by the investigator) a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters 1. Adverse events. 2. Vital signs (supine and orthostatic blood pressure, heart rate, body temperature, respiratory rate). 3. Electro-cardiogram (ECG). 4. Safety laboratory assays (clinical chemistry, haematology, and urine-analysis). Pharmacokinetics: 1. Plasma concentration of NS11821. 2. Urine concentration of NS11821. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: Saccadic eye movements: peak velocity, reaction time, inaccuracy. Smooth pursuit. Visual analogue scales (VAS) according to Bond and Lader: alertness, mood and calmness. VAS Bowdle: item *feeling high*, and composite factors *internal perception* and *external perception*. Body sway. Adaptive tracking (tracking performance). Power spectral changes in ph-EEG. Cognitive function (Cognition (Visual Verbal Learning Test)). Tapping. Pharmacokinetics: Plasma and urine concentration NS11821 metabolites. | — |
Countries
Netherlands
Outcome results
None listed