EUCTR2020-000469-18-GB进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients - Evaluating the safety and efficacy of IP2018 in depressed, erectile dysfunction patients
Initiator Pharma0 个研究点目标入组 24 人开始时间: 2020年4月1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
- 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
- Male
入选标准
- •1. Patient is male, of any ethnic origin.
- •2. Patient is aged between 18 to 55 years, inclusive.
- •3. Patient has a body mass index (BMI) of 18 to 32 mg/kg2, inclusive.
- •4. Patient has a score of 12 to 18 on the IIEF-5 Questionnaire at screening
- •5. Patient has a body weight =50 kg.
- •8. GP diagnosis of depression for over 3 months.
- •9. Patient is able to achieve one of the following erectile responses, based on the visual stimulus challenge conducted at screening:
- •>60% base penile rigidity for >1 minute but <4 minutes, cumulatively, during the 20-minute video viewing, or
- •achieve either >40% base penile rigidity for >1 minute, cumulatively, or >20% base penile rigidity for >2 minutes, cumulatively.
- •The visual stimulus challenge may be repeated once at the discretion of the Investigator, in consultation with the Sponsor’s Medical Doctor.
- •10. Mild to moderate depression, based on a score of 7 to 23 on the HAM-D at screening.
- •11. Aside from depression and ED, the patient is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs, Columbia Suicide Severity Rating Scale (C-SSRS) and clinical laboratory evaluations. Laboratory values may be re-tested at the discretion of the Investigator.
- •Should a patient score be very high on the HAM-D or positive on the CSSRS then, if they are not already under medical care and are judged to need urgent intervention, they will be referred to Crisis Resolution Services - Crisis Care, Greater Manchester Mental Health NHS Foundation Trust.
- •12. Patients must use a condom from the time of first dosing until 90 days after their final dose of trial medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception (see Section 6.3.1) 1 week prior to screening until 90 days after final dosing.
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of Investigator, may place the patient at unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this protocol.
- •2. Any history of an unstable medical or psychiatric condition (except depression) or using any medication that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study.
- •3. Any presence of a condition of the genitalia which would interfere with the application of Rigiscan and interpretation of data (such as Peyronie’s disease, hypospadias, urinary catheter, genito-urinary infection).
- •4. Primary hypoactive sexual desire or any history of hypogonadism.
- •5. Any history of radical prostatectomy.
- •6. Patients with partners who wish to become pregnant during the course of the study.
- •8. Patient has any of the following on assessment of vital signs at screening or predose on Day 1 of each treatment period (vital signs may be repeated at the discretion of the Investigator):
- •Supine systolic blood pressure >150 mmHg;
- •Diastolic blood pressure >90 mmHg;
- •Decrease in systolic blood pressure =20 mmHg upon standing with or without symptoms.
- •11. A QTc interval of >430 msec in triplicate ECGs taken at screening or a family history of Long QT syndrome.
- •14. History of suicidal thoughts or ideation as determined by a yes” answer to any of the questions on the C-SSRS at any point during the previous 12 months or evidence from medical history.
- •16. Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra® or other therapy for ED for the duration of the study.
- •20. Use of any drugs that are inhibitors or substrates of CYP2D6 and unable to stop taking them during the study, and during the 21 days before, or within 7 half-lives (whichever is longer) of dosing, until the end of the study.
- •25. History of gastric bypass surgery or other GI problems which could affect absorption of drug.
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