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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT02404532
Eligibility Criteria:
Inclusion Criteria:
* Healthy males or healthy non-pregnant females 18 to 65 years of age at the time of informed consent who are willing to either practice abstinence or 2 barrier methods of birth control or 1 barrier method and an oral contraceptive method.
* Subject must be in good general health (not suffering from a serious chronic mental or physical disorder that has required or may in the near future require urgent medical care).
* Body mass index between 19 to 32 kg/m2 (inclusive).
Exclusion Criteria:
* Subject with a history of skin sensitivity to adhesive medical tape or metals.
* Subject with a history or evidence of a medical condition that would expose him or her to an undue risk of a significant adverse event (AE) or interfere with assessments of safety during the course of the trial.
* Subject has received any investigational product within the last 30 days.
* Subject has a current history of drug or alcohol dependence that meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
* Subject has the presence of cognitive impairment.
* Subject currently taking antipsychotic medication.
* Subject with a terminal illness.
* Subject with a history of chronic dermatitis.
* Subject with a history of gastrointestinal surgery that could impair absorption.
* Female subject who is breastfeeding and/or who has a positive serum pregnancy test result prior to receiving trial medications.
* Sexually active women of childbearing potential (WOCBP) who will not commit to using 2 forms of approved birth control methods or who will not remain abstinent during this trial and for 30 days following the last dose of trial medication.
* Sexually active males who will not commit to using 2 of the approved birth control methods or who will not remain abstinent for the duration of the trial and for 90 days following the last dose of trial medication.
* No permanent physical residence.
* A diastolic blood pressure reading \>95 mm Hg or symptomatic hypotension.
* Any subject who, in the opinion of the investigator, should not participate in the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02404532
Study Brief:
Protocol Section:
NCT02404532