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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT04559568
Eligibility Criteria:
Inclusion Criteria:
* Are overtly healthy as determined through medical evaluation including medical history and physical examination
* Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
* Have had a stable weight for one month prior to screening and enrollment (less than \[\<\]5 percent \[%\] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment
* Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Exclusion Criteria:
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
* Have blood pressure of greater than (\>)160/90 millimeters of mercury (mmHg) and pulse rate \<50 or \>100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
* Have a history of fructosuria
* Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04559568
Study Brief:
Protocol Section:
NCT04559568