EUCTR2018-001988-23-HU进行中（未招募）1 期
Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg in pediatric patients with suspected growth hormone deficiency (GHD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- All
入选标准
- •1. Male or female pediatric patients from 2 to less than 18 years of age;
- •2. Suspected GHD based on auxological and clinical criteria;
- •3. Indication for the performance of provocative GHST
- •4. A subject with sex steroid priming prior to GHSTs that are part of the standard diagnostic procedures must also have sex steroid priming for the macimorelin GHST.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Lack of suitability for the trial:
- •1. Established diagnosis of a disease that is sufficient to explain growth deficiency or metabolic disorders that are also associated with GHD (e.g. Turner syndrome, skeletal dysplasias, malnutrition, etc.);
- •2. Ongoing GH therapy;
- •3. Subjects with a medical history and clinical signs of a not adequately treated thyroid dysfunction, or subjects who had a change in thyroid therapy within 30 days prior to anticipated macimorelin test day;
- •4. Untreated hypogonadism or not on a stable substitution treatment within 30 days prior to the anticipated macimorelin test day;
- •5. Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levodopa, and dopamine agonists) or provoking the release of somatostatin; antimuscarinic agents (atropine);
- •6. Concomitant use of a CYP3A4 inducer (e.g. carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort);
- •7. Concomitant use of a CYP3A4 inhibitor;
- •8. Medical history of ongoing clinically symptomatic psychiatric disorders;
- •9. Cushing disease or subjects on supraphysiologic glucocorticoid therapy within 30 days prior to the anticipated macimorelin test day;
- •10. Participation in a trial with any investigational drug within 30 days prior to trial entry;
- •11. Vigorous physical exercise within 24 hours prior to the macimorelin test dose.
- •Safety concerns:
- •12. Known hypersensitivity to any of the constituents of the macimorelin preparation;
- •13. Prolonged ECG QT interval, defined as QTc > 500 msec;
- •14. Concomitant treatment with any drugs that might prolong QT/QTc (see list of drugs at http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm
- •Note: A subject who receives such treatment will not be a candidate for this study, if his/her condition does not allow for a treatment-free period of at least 5 elimination half-lives of the drug that might prolong QT/QTc before the GHST;
- •15. Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (AST, ALT, GGT > 2.5 x ULN; creatinine or bilirubin > 1.5x ULN);
- •16. Current active malignancy other than non-melanoma skin cancer;
- •17. Girls of childbearing age without effective contraception, defined as hormonal contraception or use of condom (male or female) and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD).
- •Administrative reasons:
- •18. Lack of ability or willingness to give informed consent by the subject and/or his/her legal representative;
- •19. Anticipated non-availability for trial visits/procedures.
研究者
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