Status:
COMPLETED
A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects
Lead Sponsor:
VIVUS LLC
Conditions:
Avanfil ADME
Semen Exposure
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purposes of this study are to: * Determine the effect of the study drug on sperm and semen of healthy young male subjects. * Determine the effect of age on the amount of study drug in the blood o...
Detailed Description
This single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the United States, in which at least 18 young (18-45 years, inclusiv...
Eligibility Criteria
Inclusion
- Cohort A: Adult male subjects of 18 to 45 years of age inclusive Cohort B: Adult male subjects at least 65 years of age
- All subjects must be medically healthy with no clinically significant screening results.
- Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of Avanafil and be willing to not donate sperm for 90 days after dosing.
Exclusion
- Major exclusion criteria for all subjects include:
- History or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, 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
- 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 screening
- Use of any investigational drug within 30 days of screening
- Use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening
- History of alcohol or drug abuse within 18 months, history of smoking within 6 months
- Positive urine alcohol test
- Positive urine drug screen
- Positive urine cotinine test, positive serology for HIV, HCV, HBsAg
- Young males who have undergone vasectomy cannot participate in this-study
- Additional exclusion criteria are listed in Section 4.2.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00914511
Start Date
May 1 2009
End Date
June 1 2009
Last Update
January 7 2011
Active Locations (1)
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1
MDS Pharma Services
Tempe, Arizona, United States, 85283