ISRCTN11913515已完成1 期
A randomized, single-blind, placebo-controlled study of the effects of repeat doses of NT-814 on oestradiol and other sex hormone concentrations in healthy pre-menopausal female volunteers
KaNDy Therapeutics0 个研究点目标入组 33 人开始时间: 2020年9月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33624806/ (added 13/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy, female, aged 18 to 45 years inclusive (age at time of informed consent)
- •2. Have regular (approximately) monthly menstrual periods
- •3. Be able and willing to understand and comply with the requirements of the study and give written informed consent
- •4. Have a body mass index (BMI) in the range 18.0 to 32.0 kg/m2 and body weight not less than 40.0 kg
- •5. Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
- •6. Not be pregnant and not lactating, with no intention of pregnancy during study treatment
- •7. Agree to use two acceptable methods of birth control, one of which a barrier method with spermicide for the duration of participation in the study and 30 days after the last dose of study medication
排除标准
- •1. Been previously enrolled in this study or any other study with NT-814
- •2. Have clinically significant findings on physical examination at screening
- •3. Have any relevant medical history, in particular: liver or renal insufficiency, cholecystectomy, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other condition that the Investigator considers should exclude the subject
- •4. Undergone bilateral oophorectomy and/or hysterectomy
- •5. Have positive serology for any of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- •6. Have any serum biochemistry and full blood count outside the normal reference ranges and considered by the Investigator to be of clinical significance, assessed at screening and on Cycle 1 Day 21/22. Haemoglobin must not be less than 11.0 g/dL at either screening or Day 21/22
- •7. Have Stage 2 or higher hypertension (supine/semi-recumbent systolic blood pressure [SBP] >160 mmHg; diastolic blood pressure [DBP] >100 mmHg or Stage 1 hypertension (supine/semi-recumbent SBP 140 160 mmHg; DBP 90 100 mmHg associated with indication for treatment i.e. evidence of end-organ damage, diabetes or a 10 year cardiovascular risk, estimated using a standard calculator, e.g. https://qrisk.org/three/, greater than 20%. Measurements are based on the mean of duplicate values recorded at least 2 minutes apart and are assessed at screening, on Cycle 1 Day 21 or 22 and pre-dose on Cycle 2 Day 1 or 2
- •8. Have clinically relevant abnormal 12 lead ECG, including QTcF >450 msec, QRS interval >120 msec, PR interval >220 msec, assessed at screening, on Cycle 1 Day 21 or 22 and pre-dose on Cycle 2 Day 1 or 2; if any value are out of range, two repeated assessments are permitted at that time point and the value based on the mean of the triplicate measure
- •9. Have a history of any grade of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders 5 criteria (or later edition if applicable) within 6 months before Screening or have a positive test result(s) for drugs of abuse (opiates including methadone, cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening, Cycle 1 Day 21 or 22, or Cycle 2 Day 1 or 2
- •10. Have a clinically significant acute illness within 7 days before first study drug administration
- •11. Been drinking, on average, more than 6 cups of coffee or other caffeinated beverages daily (where each cup of coffee or beverage contained approximately 120 mg caffeine)
- •12. Been smoking more than an average of 5 cigarettes (or equivalent) per day
- •13. Use any non-permitted prior prescription, over-the-counter or herbal medication
- •14. Have a history of clinically significant drug and/or food allergies, particularly known allergy to any of the excipients used in the study medications
- •15. Receive an investigational drug (including vaccines) or use an investigational medical device within 3 calendar months before the first dose of study medication or currently enrolled in an investigational study
- •16. Have major surgery within 2 calendar months before first dose of study medication,
研究者
相似试验
已完成
不适用
A double-blind, placebo controlled, randomized study comparing the effects of amitriptyline on dyspeptic symptoms in patients with functional dyspepsiaDigestive SystemFunctional dyspepsiaDyspepsiaISRCTN76116512Academic Medical Center (AMC), Department of Gastroenterology (The Netherlands)38
已完成
2 期
The PIROUETTE trialSpecialty: Cardiovascular disease, Primary sub-specialty: Heart FailureUKCRC code/ Disease: Cardiovascular/ Other forms of heart diseaseCirculatory SystemMyocardial fibrosisISRCTN91621241niversity Hospital of South Manchester NHS Foundation Trust94
已完成
2 期
A randomised, double blind, placebo-controlled study of RAD001 (Everolimus) in the treatment of neurocognitive problems in tuberous sclerosisTuberous sclerosisNervous System DiseasesISRCTN09739757Cardiff University (UK)38
已完成
2 期
Study to evaluate the safety and efficacy of CCX168 in subjects with renal vasculitis on background cyclophosphamide treatmentRenal VasculitisCirculatory SystemRenal vasculitisISRCTN53663626ChemoCentryx, Inc. (USA)60
已完成
3 期
A study to evaluate if different doses of KVD900 are safe and effective in treating attacks in patients with hereditary angioedemaHereditary angioedema (HAE) type I or type II.Haematological DisordersHereditary Angioedema Type I or IIISRCTN14762022KalVista Pharmaceuticals Ltd136