Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01926366
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures.
2. All male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after dose administration. A male subject is considered biologically capable of having children even if his sexual partner is sterile or using contraceptives.
3. Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
4. Subjects must be fluent in English.
Exclusion Criteria:
1. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality.
2. A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration.
3. A history of seizure.
4. A history of head trauma, including closed head injury with loss of consciousness.
5. Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior.
6. Urine drug screen positive for a drug of abuse
7. A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01926366
Study Brief:
Protocol Section:
NCT01926366