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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01950520
Eligibility Criteria:
* INCLUSION CRITERIA:
* Generally healthy
* Males between the age 18-35 years
* Written informed consent.
EXCLUSION CRITERIA:
* BMI less than 18.5 or greater than 25.0 kg/M(2)
* History of cardiovascular disease such as congestive heart failure, heart block, clinically abnormal EKG as determined by investigators
* History of liver disease or ALT serum level greater than two times the laboratory upper limit of normal
* History of kidney diseases or renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation)
* History of cancer or bariatric surgery
* History of diabetes mellitus or fasting serum glucose \> 126 mg/dL
* History of hypo- or hyper-thyroid or abnormal TSH, except minor deviations deemed to be of no clinical significance by the investigator.
* History of asthma, chronic obstructive pulmonary disease and glaucoma
* Psychological conditions, such as (but not limited to) claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study
* Weight change \>5 percent in the past 6 months or a trained athlete
* Blood pressure greater than 140/90 mmHg or current antihypertensive therapy
* Iron deficiency (Hemoglobin \<13.7 g/dL and Hematocrit \<40.1%)
* History of illicit drug, opioids, or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE greater than or equal to 2) (95)
* Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism
* Current medications that may have interactions with study drugs as determined by the investigators
* History of adverse or allergic reactions to the study drugs
* Daily caffeine intake \>500 mg (about 4 cups) and have withdrawal symptoms
* Current smoker or user of tobacco products
* Cannot commit to the schedule of visits to the Clinical Research Center (CRC) as required by the study timeline
* Have had previous radiation exposure within the last year (X-rays, PET scans, etc.) that would exceed research limits (please let us know if you have received radiation for research purposes)
* Have inflexible dietary restrictions
* Any other reason that the investigator thinks would make interpretation of the study results difficult.
* For subjects having an MRD (cOHORT 3), history of pacemaker, metallic heart valves, aneurysm clip, pedicle screws, metallic foreign body in eye, or other metallic implant.
* For subjects receiving mirabegron (Cohort 3), a diagnosis of bladder outlet obstruction or the use of antimuscarinic medications for the treatment of overactive bladder.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01950520
Study Brief:
Protocol Section:
NCT01950520