A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
研究概览
简要总结
This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75
- •History of hypogonadism
- •In good health based on medical history, physical examination, and clinical laboratory tests
- •Serum testosterone deficiency
- •One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
- •Body mass index (BMI) between 18 and 35 kg/m^2
- •All screening lab tests within 20% of the normal range (exceptions are liver function tests)
- •HIV, Hepatitis B and C negative
排除标准
- •Previous use of FE 999303
- •Prostate cancer
- •Breast carcinoma, patient or partner
- •Palpable prostatic mass(es)
- •Serum PSA levels ≥3 ng/dL
- •Chronic use of any drug of abuse
- •Lower urinary tract obstruction
- •Clinically significant anemia or renal dysfunction
- •Cardiovascular disease
- •Hyperparathyroidism or uncontrolled diabetes
- •Generalized skin irritation or significant skin disease
- •Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
- •Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
- •Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
- •Sleep apnea
- •Untreated depression
- •Subject with a partner who is pregnant or will not use contraception
研究组 & 干预措施
Testosterone 2.50 mL (hand)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.
干预措施: Testosterone Gel (FE 999303) (Drug)
Testosterone 1.25 mL (applicator)
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days.
干预措施: Testosterone Gel (FE 999303) (Drug)
Testosterone 2.50 mL (applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.
干预措施: Testosterone Gel (FE 999303) (Drug)
Testosterone 3.75 mL (applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days.
干预措施: Testosterone Gel (FE 999303) (Drug)
结局指标
主要结局
Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
时间窗: Days 15-21, Days 22-28 & Days 29-35
Descriptive statistics was used to present the outcome results.
次要结局
- Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.(Days 1-7)
- Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator)
- Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator)
- Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator)
- Pharmacokinetics of Total Testosterone and DHT Measuring Cavg(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand)
- Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator)
- Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator)
- Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand)
- Pharmacokinetics of Total Testosterone and DHT Measuring Tmax(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand)
- Pharmacokinetics of Total Testosterone and DHT Measuring Cmax(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand)
- Pharmacokinetics of Total Testosterone and DHT Measuring Cmin(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand)
- Pharmacokinetics of Total Testosterone and DHT Measuring Tmin(Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand)