EUCTR2019-004764-22-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Study to Evaluate Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adre
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
- 72
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 and female subjects =18 years old at screening
- •2. Has a documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or elevated 17-OHP
- •3. Has A4 >1.5x ULN and ACTH >2x ULN at both screening and Week 4 (measured before any AM GC dose)
- •4. Has been on a stable dose of GC replacement =15 mg/day and =50 mg/day in HCe that does not vary in total daily dose from day to day for =1 month before screening without any evidence of non-adherence to the GC regimen during this period (stress dosing is allowed)
- •5. For subjects with the salt-wasting form of CAH, subject has been on a stable dose of mineralocorticoid replacement for =1 month before screening
- •6. Agrees to follow contraception guidelines. Male subjects must also agree to refrain from donating sperm throughout the treatment period and for 90 days after the last dose of study drug.
- •7. Is able to understand all study procedures and risks involved and provides written informed consent indicating willingness to comply with all aspects of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Has a known or suspected diagnosis of any other known form of classic CAH (not due to 21-hydroxylase deficiency)
- •2. Has a history that includes bilateral adrenalectomy or hypopituitarism
- •3. Has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other CRF1 receptor antagonist
- •4. Current treatment with dexamethasone as GC therapy for CAH
- •5. Is not adherent to GC or study drug dosing regimen during the Run-in Period (defined as taking <80% of expected doses as directed; stress dosing of GCs is allowed)
- •6. Shows clinical signs or symptoms of adrenal insufficiency
- •7. Has had a clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening
- •8. Uncontrolled psychiatric conditions, including but not limited to major depression, bipolar disorder, schizophrenia, or schizoaffective disorders. Symptoms including hallucinations, delusions, and psychosis are exclusionary.
- •9. Has clinically significant abnormal ECG or clinical laboratory results.
- •10. Routinely works overnight shifts
- •11. Subjects with travel plans/work schedules that result in significant and frequent changes in time zones (>2 hours) will require Medical Monitor approval for enrollment.
- •12. Females who are pregnant or nursing
- •13. Use of any other investigational drug from 30 days or 5 half-lives (whichever is longer) before screening to the end of the study
- •14. Use of the following drugs from 30 days or 5 half-lives (whichever is longer) before Day 1 to the end of the study:
- •a. Rosiglitazone, aromatase inhibitors, testosterone, growth hormones, or any other medication or supplement that could impact subject safety or confound interpretation of study results
- •b. The drugs:
- •i. Moderate to strong inhibitors and/or inducers of CYP3A4
- •ii. Sensitive substrates or narrow-therapeutic-range substrates of CYP3A4 (except hormonal contraception containing ¿20 ¿g ethinyl estradiol)
- •iii. Sensitive substrates or narrow-therapeutic-range substrates of BCRP (except those that can be administered QD in the morning, separated by approximately 10 hours from evening administration of study drug)
- •15. Use of any anticoagulants or antiplatelet therapies other than aspirin within 30 days before screening
- •16. Has a history of an active bleeding disorder
- •17. Donation or receipt of blood from 90 days before Screening to the end of the study; donation or receipt of platelets, white blood cells, or plasma from 30 days before Screening to the end of the study
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