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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT02088203
Eligibility Criteria:
Inclusion Criteria:
* Are an overall healthy adult
* Are male or female, ages 18-65 at time of consent
* Are female and of childbearing potential, you must agree to use one of the approved contraception method \[(i.e., barrier method, intrauterine and cervical devices, oral contraceptives, hormonal injections (Depo Provera®), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence)\], prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.
* Have a BMI within the range 18.5-40 kg/m2 (this is a measure of your height to weight ratio).
* Are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Have no significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, endocrine, neurological and psychiatric disease
* Have overall normal clinical laboratory tests as deemed by the physician
Exclusion Criteria:
* Have a prior history of Type 1 or 2 diabetes
* Are a female who is pregnant or lactating.
* Are taking certain medications (these will be reviewed with you by the study staff).
* Are anticipating or planning to have surgery during the study period.
* Are a current smoker or have smoked within the previous 6 months.
* Have had a weight change of more than 5% in the last 2 months.
* Are taking prescription or over the counter medications or supplements for weight loss.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02088203
Study Brief:
Protocol Section:
NCT02088203