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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Healthy young males
Healthy young males age 18-45, inclusive
干预措施: avanafil 200mg (Drug)
Elderly males
Elderly males 65 years of age and older
干预措施: avanafil 200mg (Drug)
结局指标
主要结局
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
时间窗: pre-dose (baseline) through 24 hours post-dose
次要结局
- adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study.(pre-dose (baseline) through 24 hours post-dose)