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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01143493
Eligibility Criteria:
* INCLUSION CRITERIA FOR PART 1 AND 2:
* Male or female 18 years of age or older at the time of enrollment
* Must be a participant in the EPR study
* Are genotyped and determined to be heterozygote or homozygote carriers of one of the two hGR SNPs (hGR9B A3669G and hGR N363S) or are wild type at the SNP location
* Able to understand and provide written informed consent to participate in the study
* Able to travel to the CRU
* Willing and able to fast for periods of up to 12 hours during the study
* Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).
EXCLUSION CRITERIA:
Exclusion Criteria for Part 1
Participants with the following history will be excluded from part 1 of the study:
* Any glucocorticoid use within approximately 14 days of scheduled visit 1 including oral, inhaled, nasal sprays, and cream (dermal/mucosal)
* Pregnant or currently breastfeeding
* Planning to use certain medications because they can affect test results.
* Any condition that, in the investigator's opinion, places the participant at undue risk for complications.
Exclusion Criteria for Part 2
Participants with the following history will be excluded from part 2 of the study to avoid confounding the dexamethasone suppression test:
* Any glucocorticoid use within approximately 14 days of scheduled visit 2 including oral, inhaled, nasal sprays, and cream (dermal/mucosal)
* Pregnant or currently breastfeeding
* Currently enrolled in another clinical research study and/or is receiving an investigational agent for any reason
* Does not agree to take dexamethasone at scheduled time
* Planning to use certain medications such as corticosteroids, estrogens, or tetracyclines prior to the visit 2, because they can affect test results. If the participant is willing to withhold these medications for 14 days, then the participant will be allowed to participate in visit 2.
Participants with the following history will be excluded from part 2 of the study because the dexamethasone may cause potential harm to the participant:
* High blood pressure of 160/10 mm Hg or above.
* Active coronary artery disease (angina) or moderate to severe heart failure stage New York Heart Association III-IV
* Renal failure
* Glaucoma
* Uncontrolled psychiatric disorders such as bipolar disorder or schizoaffective disorder
* Active systemic fungal infection
* Prior hypersensitivity reaction to Dexamethasone
* Currently receiving treatment for cancer (certain cancers, like lung cancer make adrenocorticotropic hormone (ACTH), and all induce stress)
* Any condition that, in the investigator's opinion, places the participant at undue risk for complications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01143493
Study Brief:
Protocol Section:
NCT01143493