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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01657851
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to give written informed consent
* Males who are 18 - 45 years of age, inclusive
* Verified diagnosis "healthy"
* Body mass index 20-25 kg/m2 (inclusive)
* Negative results of test for HIV, syphilis, hepatitis B (HBs Ag) and hepatitis C
* Adequate, liver, and renal function
* adequate contraception
Exclusion Criteria:
* Poor metabolizer for CYP2D6
* Medical history of allergy
* Medical history of medicines intolerability
* Chronic diseases
* History of surgery on gastrointestinal tract
* History of prostate cancer
* History of breast cancer
* Acute infectious disease
* Regular use of drugs
* Intake of medicines with high influence on liver function or haemodynamics
* Use of drugs that influence activity of CYP2D6 and CYP3A4
* Use of Dutasteride less than 6 months before study entry or alpha-blockers less than 2 weeks before study entry
* Blood donation (≥450 mL of blood or plasma) less than 2 months before study start
* History of regular alcohol consumption
* A positive urine drug or alcohol
* Smoking more than 10 cigarettes a day
* Participation in Phase I clinical trials less than 3 months before study entry
* History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis
* Subjects who have consumed the following foods or drinks within 7 days prior to the first dose of study medication or at any time during the clinical phase of the study: grapefruit juice; red wine; grapefruit or cruciferous vegetables (watercress, broccoli, cabbage, Brussels sprouts).
* QTc ≥ 450 msec at screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01657851
Study Brief:
Protocol Section:
NCT01657851