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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00979368
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects
* BMI of 18 to 32 kg/m²
* Men only, ages 18-55 years
Exclusion Criteria:
* Sexually active men not using effective birth control if their partners are WOCBP
* Any significant acute or chronic medical illness
* Family history of Gilbert's disease
* History of Pancreatitis
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
* QTc interval \> 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)
* Second- or third-degree A-V block or clinically relevant ECG abnormalities
* History of allergy to 11-β-HSD-1 inhibitors or related compounds
* Prior exposure to BMS-816336
* Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
* Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
* Use of any glucocorticoid topical creams within 4 weeks of study drug administration
* Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00979368
Study Brief:
Protocol Section:
NCT00979368