NL-OMON55229已完成不适用
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First in Man, Single Escalating Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GAL-475 in Healthy Male Volunteers and Male Subjects with Sleep Apnea - CS0352-200069
eurim Pharmaceuticals Ltd.0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Part 1: Healthy male subjects aged from 18 to 55 years old, inclusive, at
- •2. Part 2: Male subjects with confirmed moderate to severe (AHI >=20) central
- •sleep apnea or mixed sleep apnea diagnosis aged from 18 to 80 years old,
- •inclusive, at Screening. The inclusion of patients with a cerebrovascular
- •accident (CVA) is allowed if these patients have been stabilized, with no
- •episodes occurring, as judged by the principal investigator for at least 3
- •years prior to screening. Furthermore, upon discretion of the
- •investigator, cardiovascular patients may be included if they:
- •a. Have no history of hospital admission for the last 6 months prior to
- •b. Have had a stable cardiovascular disease/condition for the last 3 years
- •prior to screening.
- •c. Have been on a stable regimen of medication for the last 6 months prior to
- •Upon discretion of the investigator, diabetes type 2 patients and patients with
- •(stable) high blood pressure may also be included if they have been on a stable
- •treatment regimen for at least 3 months prior to screening.
- •3. Part 2: Documented Continuous Positive Airway Pressure (CPAP) intolerance or
- •CPAP-naïve.
- •4. Part 2: patients with documented Continuous Positive Airway Pressure (CPAP)
- •poor compliance (poor compliance is defined as self-reported use of CPAP of
- •less than 4 hours per night for less than 70% of nights) are eligible only if
- •CPAP is not used at all for 4 weeks prior to the screening.
排除标准
- •1. Subjects with a prior medical history of clinically significant
- •gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine,
- •oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or
- •any other condition which, in the opinion of the Investigator, would jeopardize
- •the safety of the subject or impact the validity of the study results.
- •2. In Part 2, subjects suffering from insomnia or other sleep disorder (other
- •than sleep apnea), or subjects that have a medical/psychological condition that
- •may lead to sleep disturbances.
- •3. In Part 2, subjects with documented CPAP compliance (compliance is defined
- •as self-reported use of CPAP 4 hours per night for 70% of nights).
- •4. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and/or alanine
- •aminotransferase (ALT) level >1.5 x upper limit of normal (ULN) at baseline.
- •Out of range values can be repeated once.
- •5. Donated blood within 90 days prior to study drug administration or donated
- •plasma within 7 days of prior to study drug administration.
- •6. Use of prescribed or over-the-counter medications within 14 days of study
- •drug administration. Occasional use of paracetamol is allowed in consultation
- •with the Investigator. Use of blood thinners and antihypertensive drugs is
- •allowed if the patient is stabilized on the specific drug dose for at least 3
- •months prior to screening and if the specific drug does not interfere with the
- •study drug, as judged on a case to case basis by the Principal Investigator.
- •Use of medications for cardiovascular disease is allowed if the patient is
- •stabilized on the specific drug dose for at least 6 months prior to screening
- •and if the specific drug does not interfere with the study drug, as judged on a
- •case by case basis by the Principal Investigator.
研究者
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