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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02062203
Eligibility Criteria:
Key Inclusion Criteria:
* Healthy, non-smoking males or females, 18 and 55 years of age, inclusive
* BMI 18.0 and 32.0 kg/m2, inclusive
* non clinically significant 12-lead ECG
* heart rate of 45 to 90 beats per minute, inclusive
* mean systolic blood pressure \<141 mmHg and mean diastolic blood pressure \< 90 mmHg
Key Exclusion Criteria:
* history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of Long QT syndrome
* significant abnormalities in liver function tests
* history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* history of Gilbert's Syndrome
* positive hepatitis panel
* seizure disorder or receiving anti-epilepsy medication for seizure disorder
* any acute or chronic condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this study or which would limit the subject's ability to complete and/or participate in this clinical study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02062203
Study Brief:
Protocol Section:
NCT02062203