A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

This study has been completed.
Sponsor:
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00914511
First received: June 3, 2009
Last updated: January 5, 2011
Last verified: January 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 32
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
MDS Pharma Services
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Shiyin Yee, PhD VIVUS, Inc.
  More Information

No publications provided

Responsible Party: Wesley Day, VP Clinical Development, Vivus, Inc.
ClinicalTrials.gov Identifier: NCT00914511     History of Changes
Other Study ID Numbers: TA-014
Study First Received: June 3, 2009
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Semen
Sperm
Avanafil
Pharmacokinetics
Elderly

ClinicalTrials.gov processed this record on September 18, 2014