A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

Vivus

Status and phase

Completed

Phase 1

Conditions

Semen Exposure

Sperm Function

Avanfil ADME

Treatments

Drug: avanafil 200mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00914511

TA-014

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.