A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

NCT ID: NCT00914511

Last Updated: 2011-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-06-30

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 of healthy subjects
• Learn about the safety of the study drug.
• Learn how subjects tolerate the study drug.

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.

Conditions

Avanfil ADME; Semen Exposure; Sperm Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy young males

Healthy young males age 18-45, inclusive

Group Type: EXPERIMENTAL

avanafil 200mg

Intervention Type: DRUG

single dose tablet of 200mg avanafil

Elderly males

Elderly males 65 years of age and older

Group Type: EXPERIMENTAL

avanafil 200mg

Intervention Type: DRUG

single tablet dose of 200mg avanafil

Interventions

avanafil 200mg

single dose tablet of 200mg avanafil

Intervention Type: DRUG

avanafil 200mg

single tablet dose of 200mg avanafil

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VIVUS LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Vivus, Inc.

Principal Investigators

Shiyin Yee, PhD

Role: STUDY_DIRECTOR

VIVUS LLC

Locations

MDS Pharma Services

Tempe, Arizona, United States

Countries

United States

Other Identifiers

TA-014

Identifier Type: -

Identifier Source: org_study_id