Investigation of cognitive function and neurophysiology.
Conditions
Interventions
Product Code: EVT 101
Pharmaceutical Form: Capsule*
Current Sponsor code: EVT 101
Other descriptive name: ENS 10,001
RO 4394127-001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Pro
RO 4394127-001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Evotec NeurosciencesGmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects will be males of any ethnic origin between 18 and 55 years of age and with a body mass index (BMI) between 19 and 29 kg/m2 inclusive. 2. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable). 3. Subjects must be right-handed. 4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions. 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
Exclusion criteria: 1. Female subjects. 2. Subjects who have received any prescribed systemic or topical medication within 5 half-lives or 14 days of the first dose administration, whichever is greater. 3. Subjects who have received any prescribed CNS medication within 30 days. 4. Subjects who have used any non-prescribed systemic or topical medication within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety. 5. Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration. 6. Subjects who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 4 months, or a marketed drug within the past 3 months. 7. Subjects who have donated blood, plasma or platelets in the past month, or who have made donations on more than two occasions within the 12 months preceding the first dose administration. 8. Subjects with a history of drug allergy to NMDA antagonists or otherwise with a history of clinically significant drug allergy. 9. Subjects who have any clinically significant allergic disease (excluding non-active hay fever). 10. Young subjects who have a supine blood pressure and supine heart rate at screening higher than 140/90 mmHg and 90 beats per minute (bpm), respectively, or lower than 80/40 mmHg and 40 bpm, respectively. 11. Subjects who consume more than 21 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits). 12. Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day (including snuff, nicotine patch, nicotine chewing gum, inhaler) and are not able to refrain from using the nicotine containing products during each of the three study periods. 13. Subjects with intake of caffeine >5 drinks per day on average. 14. Subjects who are vegetarians. 15. Subjects with an abnormal acoustic function. 16. Subjects with, or with a history of, any clinically significant respiratory, metabolic, endocrine, haematological or other major disorders. 17. Subjects with cardiac pacemakers or other electronic device or ferromagnetic metal foreign bodies (e.g. tattoo). 18. Subjects with ECG parameters outside of normal ranges as follows: PR 200 msec, QRS>120 msec, QTc >430 msec, HR 100 bpm. 19. Subjects diagnosed with disorders such as but not limited to: claustrophobia in enclosed environment, depression, anxiety, panic attack, phobias, schizophrenia, drug overdose or self-harm. 20. Subjects with a history of psychosis in a first-degree relative. 21. Subjects who cannot complete the neuropsychological test battery despite having undergone training sessions. 22. Subjects with abnormal anatomical MRI as defined by radiologist (e.g. tumours, evidence of stroke, localised with matter lesions, excessive atrophy, aneurisms, vascular malformations). 23. Subjects with, or with a history of, gastritis, peptic ulcer or similar. 24. Subjects who have any clinically significant cardiac abnormality following review of the 24 hour Holter monitoring by an external cardiologist under the care of RPL. 25. Subjects who have had a clinically significant il
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · To investigate neurophysiological changes following EVT 101 with fMRI during rest and cognitive tasks in young healthy male subjects. · To investigate the neuropsychological changes following EVT 101 using a validated battery of cognitive tasks, in young healthy male subjects. · To relate the effects of EVT 101 on fMRI signal to the effects on performance in cognitive tasks. ;Secondary Objective: · To determine plasma concentrations of EVT 101 in the subjects (pre-dose, 1, 1.5, 2, and 4h after dosing).;Primary end point(s): · change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks · change in regional Cerebral Blood Flow (rCBF, determined with ASL-MRI), after drug compared with placebo · performance scores in the cognitive tests · safety/tolerability: adverse events (AE), safety laboratory blood tests, ECG, vital signs | — |
Countries
United Kingdom
Outcome results
None listed