EUCTR2016-003060-40-GB进行中（未招募）1 期
Targeting Iatrogenic Cushing’s Syndrome with 11ß-hydroxysteroid dehydrogenase type 1 Inhibition - TICSI version 0.6
niversity of Oxford, Clinical Trials and Research Governance0 个研究点目标入组 32 人开始时间: 2016年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Male volunteers without diabetes (HbA1C < 48mmol/mol at screening)
- •BMI 20-30kg/m2
- •Age 18-60years
- •Individuals (identified from Oxford Biobank) with fasting insulin and / or glucose and / or insulin resistance as measured by HOMA IR in the 40th-60th percentile
- •BP<160/100mmHg with stable antihypertensive therapy for >3months
- •Stable lipid lowering therapy for >3 months
- •No contraindications to AZD4017 or prednisolone treatment
- •Study participants who are sexually active with a female partner of childbearing potential must be surgically sterilised, practicing abstinence, or agree, along with their partners, to use two forms of highly effective methods of birth control (i.e. condom plus another highly effective method defined below), and not rely on barrier methods and spermicide alone, from the time of screening until 1 week after final dose of study drug. Male study participants must also not donate sperm from the time of screening until 1 week after final dose of study drug.
- •Highly effective methods of contraception are defined as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (either oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (either oral [specifically Cerazette], injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner or sexual abstinence.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Age <18 or >60years
- •Body mass index <20 or >30kg/m2
- •A diagnosis of diabetes (type 1 or type 2)
- •A blood haemoglobin <120mg/dL
- •Haemorrhagic disorders
- •Anticoagulant treatment
- •Renal impairment with eGFR <60ml/min
- •Abnormal liver chemistry with AST, ALT and/or GGT and/or bilirubin >ULN
- •Glucocorticoid therapy (including inhaled, topical or oral) within the last 6 months
- •Concomitant anti-inflammatory medication including NSAIDs, disease modifying anti-rheumatic drugs (DMARDs) / steroid-sparing medications (e.g. methotrexate, sulphasalzine, hydroxychloroquine, azathioprine, leflunamide, biologics [anti-TNFa, IL-1ra])
- •Any medical condition in the opinion of the investigator that might impact upon safety or validity of the results – recent (within 2 weeks) or active infection, known liver disease, known thyroid disease, active malignancy, existing inflammatory condition (e.g. inflammatory athropathy, inflammatory bowel disease, autoimmune disease, connective tissue disease)
- •Participation in another IMP trial / study within the past 6 months
研究者
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