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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01964651
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive
* Nonsmoker
* Healthy men between 18 and 55 years, inclusive (Cohorts A and B)
* Healthy women between 18 and 58 years, inclusive (Cohort C)
* Healthy men and women between 65 and 85 years of age, inclusive (Cohort D)
* Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration (Cohorts A, B, and D)
* Not be of childbearing potential due to either tubal ligation or hysterectomy, or who are postmenopausal (Cohorts C and D)
Exclusion Criteria:
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
* Clinically significant abnormal physical examination, vital signs or electrocardiogram at screening or admission
* History of, or current, significant medical illness including (but not limited to) cardiac disease, hematological disease, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
* History of epilepsy or fits or unexplained black-outs
* Cohorts A and B only: a contraindication for spinal puncture
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01964651
Study Brief:
Protocol Section:
NCT01964651