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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT02031666
Eligibility Criteria:
Inclusion Criteria:
* During the study and for 3 months after receiving study medication, must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception), always use a condom during sexual intercourse and to not donate sperm
* Body mass index (weight \[kg\]/height \[m\]2) between 18 and 30 kg/m2 and body weight not less than 50 kg
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
* Non-smoker for 2 months prior to study participation
Exclusion Criteria:
* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, and infection
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis, physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
* Presence of sexual dysfunction (eg, abnormal libido or erectile dysfunction) or any medical condition that would affect sexual function
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen within 14 days before the first dose of the study drug is scheduled
* History of clinically significant allergies or known hypersensitivity to vitamin E
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02031666
Study Brief:
Protocol Section:
NCT02031666