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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT03508635
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent
* Weight \<= 102 kilogram (kg); body mass index (BMI) 18-30 kg/meter squared
* Morning serum cortisol in reference range
* Willing and able to communicate, participate in the whole study and to abide by study restrictions including use of contraception
Exclusion Criteria:
* Participation in any clinical research study, received treatment with any investigational drug or device, or donated blood within the previous 3 months
* Has a history of alcoholism, substance abuse, or drug abuse within 1 year; positive screen for alcohol or drugs of abuse
* Current smokers, smoked and/or used tobacco and/or nicotine-containing products within 6 months, or positive screen for carbon monoxide
* Females of childbearing potential, pregnant or breastfeeding, and/or with a positive pregnancy test
* Has a condition that could be aggravated by glucocorticoid blockade or activation
* Has clinically relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead electrocardiogram (ECG)
* Has history of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, chronic respiratory, gastrointestinal or neurological disease
* Has used systemic glucocorticoids within 12 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03508635
Study Brief:
Protocol Section:
NCT03508635