ABOUT THIS STUDY
- Informed Consent as documented by signature on the informed consent form
- Physically and psychiatrically healthy men and women
- Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days for females and 90 days for males after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children.
- Female subjects of non childbearing potential must meet at least one of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure or;
- Achieved post menopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state.
- All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
- Aged 18-35 years
- Negative pregnancy test (see exclusion criteria)
- Normal or corrected-to-normal vision
- Pregnant female subjects; breastfeeding female subjects
- considered to be healthy based on an extensive pre-study screening including
anamnesis, physical examination, laboratory investigations, vital signs, ECG, etc.
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