Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
研究概览
简要总结
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
详细描述
Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Morning serum testosterone (T) <300 ng/dL on two occasions
排除标准
- •Significant intercurrent disease
- •Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
- •Serum transaminases >2 times upper limit of normal
- •Serum bilirubin >2.0 mg/dL
- •Hematocrit <35% or >50%
- •Untreated, obstructive sleep apnea.
研究组 & 干预措施
Fasting (Treatment A)
Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state
干预措施: Oral testosterone undecanoate (containing 300 mg T) (Drug)
Very low fat diet (Treatment B)
Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat).
干预措施: Oral testosterone undecanoate (containing 300 mg T) (Drug)
Low fat diet (Treatment C)
Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat).
干预措施: Oral testosterone undecanoate (containing 300 mg T) (Drug)
Normal diet (Treatment D)
Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat).
干预措施: Oral testosterone undecanoate (containing 300 mg T) (Drug)
High fat diet (Treatment E)
Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat).
干预措施: Oral testosterone undecanoate (containing 300 mg T) (Drug)
结局指标
主要结局
Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
时间窗: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.
PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.
次要结局
未报告次要终点