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:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT04240158
Eligibility Criteria:
Inclusion Criteria:
* Subject is an ambulatory adult at least 65 years old at the screening visit
* Subject is in good health and has no clinically significant findings on physical examination
* Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state.
* Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol
* Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug
* Other inclusion criteria per protocol
Exclusion Criteria:
* Any active or unstable clinically significant medical condition
* Other exclusion criteria per protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04240158
Study Brief:
Protocol Section:
NCT04240158