EUCTR2017-001851-29-GB进行中（未招募）1 期
Randomized, multi-center, double-blind, placebo-controlled, group-comparison study to investigate safety, tolerability and pharmacodynamics of BAY2253651 after administration of a single nasal dose in 60 subjects with obstructive sleep apnea and open exploratory evaluation of safety and local tolerability of repeated doses in patients - SANDMAN trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 60
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.The informed consent must be signed before any study specific tests or procedures are done.
- •2.Male or female subject above/equal 18 years of age.
- •3.Patients must be pretreated with CPAP for OSA for at least 3 months before randomization;
- •4.AHI of 15-50 per hour after 48 hours of CPAP withdrawal documented by baseline PSG (evaluated by the site staff) and at least 4 hours of total sleep time.
- •5.Female subjects must be of non-childbearing potential, i.e. post menopausal (no menses for at least 1 year) or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy)
- •6.Men of reproductive potential must agree to use at least two adequate contraception methods when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.
- •7.Only Part B: Patients having completed Part A and had valid PSG after dosing in Part A.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection, and attending required follow up study visits.
- •2.Neck circumference above/equal 44 cm.
- •3.Not predominantly obstructive sleep apnea evidenced by previous PSG.
- •4.Severely impaired breathing (e.g. acute nasal congestion during upper airway infection).
- •5.Subject with known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations). Known severe respiratory tract allergies e.g. allergic asthma.
- •6.Intake of a nasal decongestant during the intervention time (48 before visit 1 until end of visit 2).
- •7.Use of any topical medication containing local anesthetics for nose and throat within 7 days before first investigational medicinal product (IMP) administration.
- •8.Intake of medication for insomnia within 24 hours prior to each PSG.
- •9.Participation in another trial with an investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer before or concomitant participation in another clinical study with investigational medicinal product(s).
- •10.Any other condition, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months).
- •11.Known history of severe heart failure (NYHA 3-4) or severe COPD (GOLD 3-4).
- •12.Heavy smoking, i.e. more than 20 cigarettes per day and/or unable to stop smoking during the stay in the sleep laboratory.
- •13.Suspicion of drug or alcohol abuse.
- •14.Intake of ethanol containing food and beverages from 24 hours prior to each PSG.
- •15.Regular daily consumption of more than 1 L of xanthine-containing beverages.
- •16. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site).
研究者
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