A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects
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ClinicalTrials.gov Identifier: NCT00914511 |
Recruitment Status
:
Completed
First Posted
: June 5, 2009
Last Update Posted
: January 7, 2011
|
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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 of healthy subjects
- Learn about the safety of the study drug.
- Learn how subjects tolerate the study drug.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Avanfil ADME Semen Exposure Sperm Function | Drug: avanafil 200mg | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Phase I, Single-Center, Open-Label, Non-Randomized, Two-Cohort Study to Assess the Effect of Age on the Pharmacokinetics of Avanafil And To Determine Avanafil Semen Exposure and the Acute Effect of Avanafil on Sperm Function in Healthy Young Male Subjects Following a Single Oral Dose of 200 mg |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Healthy young males
Healthy young males age 18-45, inclusive
|
Drug: avanafil 200mg
single dose tablet of 200mg avanafil
|
Experimental: Elderly males
Elderly males 65 years of age and older
|
Drug: avanafil 200mg
single tablet dose of 200mg avanafil
|
- Plasma pharmacokinetic parameters of avanafil and its metabolites will be evaluated including AUC (0-t), AUC(0-inf), Cmax, fu, t1/2, and tmax; Sperm motility, function and morphology; Avanafil exposure in seminal fluid [ Time Frame: pre-dose (baseline) through 24 hours post-dose ]
- adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study. [ Time Frame: pre-dose (baseline) through 24 hours post-dose ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914511
United States, Arizona | |
MDS Pharma Services | |
Tempe, Arizona, United States, 85283 |
Study Director: | Shiyin Yee, PhD | VIVUS, Inc. |
Responsible Party: | Wesley Day, VP Clinical Development, Vivus, Inc. |
ClinicalTrials.gov Identifier: | NCT00914511 History of Changes |
Other Study ID Numbers: |
TA-014 |
First Posted: | June 5, 2009 Key Record Dates |
Last Update Posted: | January 7, 2011 |
Last Verified: | January 2011 |
Keywords provided by VIVUS, Inc.:
Semen Sperm Avanafil Pharmacokinetics Elderly |