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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT01054859
Eligibility Criteria:
Inclusion Criteria:
* Adult male subjects,
* either 21 to 45 years of age,
* must be medically healthy with no clinically significant screening results.
Exclusion Criteria:
* Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigator; systolic blood pressure \< 90 or \>150 mmHg; diastolic blood pressure \< 50 or \> 95 mmHg;
* allergy to or previous adverse events with PDE5 inhibitors, alcohol or their constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of Day 1 dosing (Period 1);
* use of any investigational drug within 30 days of Day 1 dosing (Period 1);
* use of any prescription or over-the-counter drugs or herbal remedies within 14 days of Day 1 dosing (Period 1);
* history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol, positive cotinine test or positive urine drug screen at screening or on Day -1;
* positive serology for HIV, HCV, HBsAg. Additional exclusion criteria are listed in Section 4.2.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT01054859
Study Brief:
Protocol Section:
NCT01054859