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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT03347968
Eligibility Criteria:
Inclusion Criteria:.
* Healthy volunteers aged ≥ 18 to 45 years
* BMI between 18 -30 kg/m2
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
Exclusion Criteria:
* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
* Concurrent participation in another study of any kind
* Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
* History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.
* Impaired renal function is defined as estimated glomerular filtration rate (eGFR) \< 60 mL/minute/1.73 m2 at screening.
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening.
* History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03347968
Study Brief:
Protocol Section:
NCT03347968