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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT03777761
Eligibility Criteria:
Inclusion Criteria:
* Good health, determined by medical history, physical examination, 12-lead ECG, vital signs measurements, or clinical laboratory evaluations
* Body mass index (BMI) between 18 and 32 kg/m\^2
* Body weight between 50 and 100 kg
* Female subjects must be of non-childbearing potential
* Male subjects must agree to use contraception or be surgically sterile for at least 90 days
Exclusion Criteria:
* Significant history of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Any condition affecting drug absorption
* History of hypersensitivity or allergy to any drug compound, food, or other substance
* Single 12-lead ECG demonstrating QTcF \>450 msec for males or \>470 msec for females, or history/evidence of long QT syndrome
* History of alcoholism or drug/chemical abuse within 2 years
* Use of prescription products within 30 days prior to check in
* Use of nonprescription products within 14 days prior to check in, including vitamins, minerals, and herbal supplements
* Use of tobacco- or nicotine-containing products within 3 months prior to check in
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03777761
Study Brief:
Protocol Section:
NCT03777761