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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT03083561
Eligibility Criteria:
Inclusion Criteria:
* Overtly healthy Japanese or Caucasian
* Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)
Exclusion Criteria:
* Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females
* Have had symptomatic herpes zoster within 3 months of screening
* Have active or latent tuberculosis (TB) based on a positive medical history, examination, and/or TB test results.
* Have received live vaccine(s) within 1 month of screening or intend to during the study
* Are immunocompromised
* Have a history of constipation or have had acute constipation within 3 weeks prior to admission
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT03083561
Study Brief:
Protocol Section:
NCT03083561