Assessment of the Muscle Protein Fractional Synthesis Rate Induced by Repeated Administrations of GLPG0492 to Healthy Male Subjects and Assessment of the Safety, Tolerability and Pharmacokinetics of Repeated Administrations of GLPG0492 to Healthy Postmenopausal Women.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo
研究概览
简要总结
GLPG0492 is a selective androgen receptor modulator: the compound should help protect against (or help restore) muscle loss in case of immobilization (e.g. after orthopedic surgery) or due to aging (androgenic effect), but without anabolic effects (e.g. effect on testosterone). In the first part of the current study it will be tested whether GLPG0492 given orally to healthy male volunteers increases the protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine.
In the second part of the study, the effect of the compound on the "hormone household" in healthy, postmenopausal women will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male, age 18-50 years (for part 1), and postmenopausal subjects age 35-65 years (for part 2)
- •Body mass index (BMI) between 18-30 kg/m², inclusive.
- •For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L).
- •Women must be postmenopausal for at least 2 years with postmenopausal FSH level according to the local lab (+negative pregnancy test at screening & admission).
排除标准
- •drug or alcohol abuse
- •hypersensitivity to any of the ingredients of the study drug
研究组 & 干预措施
GLPG0492 oral solution
Multiple ascending doses once daily for 7 days (part 1) or 14 days (part 2), starting at 0.5 mg/day
干预措施: GLPG0492 (Drug)
Placebo
Placebo oral solution, once daily for 7 days (part 1) or 14 days (part 2).
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo
时间窗: Up to 7 to 10 days after last treatment
Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability
In male volunteers: effect on protein synthesis in muscle, as measured by the uptake into the muscle of intravenously infused phenylalanine
时间窗: One week
During a 5-hour infusion of phenylalanine two muscle biopsies will be taken; this procedure is performed before and after one week of treatment with GLPG0492, to determine the effect of the compound.
次要结局
- To determine the pharmacokinetic profile and metabolism after single and multiple oral doses of GLPG0492(Up to 24h hours after last treatment)
- In female volunteers: effects on hormone household.(up to 7 to 10 days after treatment.)