Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
研究概览
简要总结
The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.
详细描述
Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters [testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, ages 18-68
- •Serum total T less than or equal to 275 ng/dL
排除标准
- •Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
- •Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of >15, and/or history of prostate cancer.
- •Hematocrit of <35 or >50%
- •Body mass index (BMI) >36
- •Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL
研究组 & 干预措施
All study participants
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.
干预措施: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) (Drug)
All study participants
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.
干预措施: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose) (Drug)
All study participants
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.
干预措施: Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food) (Drug)
All study participants
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.
干预措施: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose) (Drug)
结局指标
主要结局
Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
时间窗: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses
Sampling to determine serum T AUC post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T AUC with food (Day 7) and fasting (Day 8) in Treatment Period 3.
Serum Testosterone Average Concentration (Cavg) (ng/dL)
时间窗: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses
Sampling to determine serum T Cavg post AM and PM doses and for 24 hours in Treatment Periods 1, 2, and 4. Sampling to determine serum T Cavg post AM dose with food (Day 7) and fasting (Day 8) in Treatment Period 3.
次要结局
未报告次要终点