NCT02718378已完成1 期
A Phase I, Double-blind, Randomised, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Dosages of Estetrol in Healthy Men
Pantarhei Oncology B.V.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
The current study is designed as a phase Ib multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral administration for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, age between 40 and 70 years (both inclusive);
- •Good physical and mental health as judged by the Investigator determined by medical history, physical examination (including prostate palpation), clinical laboratory, vital signs and ECG recording;
- •Body mass index between ≥ 18.5 and ≤ 30.0 kg/m2;
- •Normal prostate-specific antigen (PSA) value (< 3.0 ng/mL);
- •Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. Men who have been vasectomized less than 4 months prior to study start must follow the same restrictions as non-vasectomized men;
- •Men must agree not to donate sperm from the first dose until 90 days after the last dose;
- •Ability to communicate well with the Investigator and to comply with the requirements of the entire study;
- •Willing to give informed consent in writing.
排除标准
- •Any clinically significant abnormality following review of medical history, laboratory results, physical examination and ECG at screening as judged by the Investigator;
- •Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study drugs;
- •Previous use of steroids within:
- •8 weeks for oral preparations
- •4 weeks for transdermal preparations
- •Any time for injections;
- •Contraindications for steroids or estetrol;
- •Prostate hyperplasia or micturition problems that suggest the presence of prostate hyperplasia;
- •Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or C (or previously treated);
- •Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication before screening;
- •Hypersensitivity to the active substances or to any of the excipients of the investigational product or placebo therapy;
- •Use of probiotics (as present in dairy products, fortified foods etc.) during the 3 months before screening and during the clinical study;
- •Use of one or more of the following medications:
- •Antihypertensive drugs
- •Present use or use within 30 days before the start of the study drug of the following drugs: aprepitant, bosentan, armodafinil, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, glucocorticoids, topiramate, felbamate, rifampicin, clobazamechinacea; vemurafenib, non-nucleoside reverse transcriptase inhibitors, griseofulvin, ketoconazole, and herbal remedies containing Hypericum perforatum
- •Any medication (including over-the-counter products) within 14 days before first dosing except for occasional non-steroidal anti-inflammatory drugs (NSAIDs; e.g. ibuprofen); paracetamol is not permitted
- •Use of antibiotics;
- •Administration of any other investigational drug within 3 months before first dosing;
- •Loss of more than 400 mL blood during the 3 months before screening, e.g. as a blood donor, or intention to donate blood in the 3 months after completing the study;
- •Subjects with a history of (within 12 months) alcohol or drug abuse or with a positive result at screening, for tests of:
- •alcohol intake
- •drug abuse;
- •Currently smoking or smoked within the last 6 months before screening.
研究组 & 干预措施
No added active
Placebo Comparator
placebo without estetrol
干预措施: placebo (Drug)
estetrol dose level 1
Active Comparator
estetrol given in dose level 1
干预措施: estetrol (Drug)
estetrol dose level 2
Active Comparator
estetrol given in dose level 2
干预措施: estetrol (Drug)
estetrol dose level 3
Active Comparator
estetrol given in dose level 3
干预措施: estetrol (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: 28 days
Changes from baseline measurements considered clinically significant by the Investigator will be reported as AEs.
Change from baseline in hormone levels
时间窗: 28 days
The serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), Estradiol (E2), total testosterone and free testosterone levels (actual values as well as percentage change from pre-dose concentration) will be listed and summarized descriptively by treatment group.
次要结局
- Change from baseline in glucose levels(28 days)
- Change from baseline in sex-hormone binding globulin (SHBG) levels(28 days)
- Pharmacokinetic effect of estetrol(28 days)
- Change from baseline in haemostasis parameters(28 days)
- Change from baseline in lipid parameters(28 days)
- Change from baseline in bone turnover markers(28 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy SubjectsHealthyNCT04532957KBP Biosciences24
终止
1 期
Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive ImpairmentMild Cognitive ImpairmentAlzheimer's DiseaseNCT02573740AbbVie8
终止
1 期
Study on Tolerability of Repeat i.c.v. Administration of sNN0031 Infusion Solution in Patients With PDParkinson's DiseaseNCT02408562Newron Sweden AB1
已完成
1 期
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With SchizophreniaSchizophreniaNCT01457339Shire31
招募中
1 期
A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy VolunteersHealthyNCT06637865Immutep S.A.S.79