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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00400335
Eligibility Criteria:
Inclusion criteria:
* Are healthy.
* Have a BMI within range of 19-32 kg/m2.
* Have not taken dutasteride for one year, or finasteride for the past 3 months.
* Have a screening PSA \< 2.0ng/mL.
Exclusion criteria:
* Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
* Have a trigliceride level =500mg/dL.
* Have abnormal thyroid or hormone levels.
* Would donate more than 500 ML of blood over a 2 month period.
* Physician does not think it is a good idea for you to participate in the trial.
* Are unwilling to abstain from alcohol during the study.
* Have a positive urine drug screen test.
* Plan to change your smoking habits during the course of the trial.
* Have Hepatitis C, Hepatitis B, or HIV.
* Have a lab or ECG abnormality.
* Have high or low blood pressure.
* Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00400335
Study Brief:
Protocol Section:
NCT00400335