Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 With Oral Curcumin in Normal Men With Experimental Hypogonadism
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- average serum testosterone after dosing on day 2
研究概览
简要总结
This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix, which is approved for the treatment of prostate cancer, and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose.
详细描述
The study will have three phases: a screening period, a 3-day drug exposure period, and a one-month recovery period (see Table 1, Experimental Design).
Screening Visit: At screening, study investigators will consent subjects, perform an interview and physical examination; blood samples for measurement of hormones (T,
DHT, Estradiol (E2), FSH and LH), routine hematology, chemistry and hepatic function and a DNA sample for UGT2B17 genotype will be obtained from the buccal mucosa and a spot urine specimen obtained for a testosterone glucuronide/androsterone glucuronide ratio (a marker of endogenous UGT2B17 activity). No drugs will be administered in the screening period. The screening visit should take approximately 60 minutes.
Day 1 (15-minute visit): Blood pressure and heart rate will be measured prior to the administration of Relugolix 120 mg orally on an empty stomach.
Day 2 (9 hour stay): Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two ensures. The first dose of oral testosterone will be administered at 0900 (+/- 30 minutes) in the morning with two Ensures. After drug administration, subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose, 0.5, 1, 1.5 2, 3, 4, 6, and 8 hours after the morning dose and will have the iv removed.
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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male between 18 and 55 years of age
- •agrees to not participate in another drug research study for the duration of this study
- •agrees to not donate blood during the study
- •subject provided written (personally signed and dated) informed consent before completing any study-related procedures
- •subject able and willing to comply with the protocol
- •subject able and willing to not take medications other than the study drug for the duration of the study
排除标准
- •subject has poor general health, determined by medical history or physical exam
- •subject have an abnormal evaluation on screening exam (consisting of serum chemistry, hematology and baseline hormone levels)
- •subject have a known history or current use of alcohol drug or steroid abuse and/or the use of more than 3 alcoholic beverages per day
- •History of current testosterone use
- •History of testicular disease or severe testicular trauma
- •History of major psychiatric disorder
- •subject participated in a hormonal drug study within the past month
- •Subject or his partner(s) NOT willing to use an accepted method of contraception during the study
- •History of Bleeding disorders or current use of anti-coagulants
研究组 & 干预措施
Arm 1 Oral testosterone undecanoate without Curcumin
Oral testosterone undecanoate 237 mg Day 2
干预措施: Testosterone Undecanoate 237 MG Oral Capsule (Drug)
Arm 2 Oral testosterone undecanoate with Curcumin
Oral testosterone undecanoate 237 mg & Curcumin 630 mg Day 3
干预措施: Curcumin (Dietary Supplement)
Arm 2 Oral testosterone undecanoate with Curcumin
Oral testosterone undecanoate 237 mg & Curcumin 630 mg Day 3
干预措施: Testosterone Undecanoate 237 MG Oral Capsule (Drug)
Relugolix 120 mg single dose
All subjects will received Relugoliz on Day 1
干预措施: Relugolix 120Mg Tab (Drug)
结局指标
主要结局
average serum testosterone after dosing on day 2
时间窗: 24 hour period (between dosing at beginning of day 2 and end of day 2)
average serum testosterone after dosing on day 3
时间窗: 24 hour period (between dosing at beginning of day 3 and end of day 3)
Maximum concentration
时间窗: Cmax during 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
time to maximum concentration
时间窗: T max during 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
area-under-the curve
时间窗: 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
elimination phase half-life
时间窗: 24 hour period (between dosing at beginning of day 2 and 3 and end of day 2 or day 3)
次要结局
未报告次要终点
研究者
John Amory
Professor, DOM - General Internal Medicine
University of Washington