A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects - Full Text View

Sponsored by:	VIVUS, Inc.
Information provided by:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00914511

Purpose

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	Intervention	Phase
Avanfil ADME Semen Exposure Sperm Function	Drug: avanafil 200mg	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	May 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Healthy young males: Experimental Healthy young males age 18-45, inclusive	Drug: avanafil 200mg single dose tablet of 200mg avanafil
Elderly males: Experimental Elderly males 65 years of age and older	Drug: avanafil 200mg single tablet dose of 200mg avanafil

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, inclusive) male subjects in Cohort A and 14 elderly (65 years or older) males in Cohort B will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. Seminal fluid and plasma will be collected from Cohort A, whereas only plasma samples will be collected from Cohort B.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914511

Contacts

Contact: Daniel Zamfir, BS

602-437-0097 ext 67188

daniel.zamfir@mdsinc.com

Locations

United States, Arizona
MDS Pharma Services	Recruiting
Tempe, Arizona, United States, 85283
Principal Investigator: Dennis Swearingen, M.D.

Sponsors and Collaborators

VIVUS, Inc.

Investigators

Study Director:

Shiyin Yee, PhD

VIVUS, Inc.

More Information

No publications provided

Responsible Party:	Vivus, Inc. ( Wesley Day, VP Clinical Development )
Study ID Numbers:	TA-014
Study First Received:	June 3, 2009
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00914511 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Semen
Sperm
Avanafil
Pharmacokinetics
Elderly

Study placed in the following topic categories:

Healthy
Spastic Paraplegia Epilepsy Mental Retardation

ClinicalTrials.gov processed this record on September 03, 2009