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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03500627
Eligibility Criteria:
Key Inclusion Criteria:
* Body Mass Index (BMI) between 18 and 32 kg/m\^2.
* Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG), as judged by the investigator.
* Female subjects may not be pregnant, lactating, or breastfeeding.
* Subjects must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and Check-in.
Key Exclusion Criteria:
* Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease, or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
* History of malignancy (other than successfully treated basal cell or squamous cell skin cancer).
* History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant.
* Has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study.
* Has used medications that affect gastrointestinal motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day 1.
* Has used prescription or over-the-counter medication, vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to Day 1.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03500627
Study Brief:
Protocol Section:
NCT03500627