EUCTR2018-003083-30-BE进行中（未招募）1 期
The effect of hydroxychloroquine sulphate on hedonic food intake, appetite-related sensations and gastrointestinal hormone release in healthy female subjects - PLAQHV
Z Leuven0 个研究点目标入组 10 人开始时间: 2019年1月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- Female
入选标准
- •Subject is female between 18 and 65 years of age.
- •Subject has a BMI between 18 and 25 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
- •Subject is allowed to take 2 Plaquenil capsuls for one visit with a maximal dose of 6.5 mg hydroxychloroquine sulphate per kg bodyweight.
- •Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject is under age of legal consent, male, pregnant or breastfeeding.
- •Subject with a BMI = 18 kg/m² or BMI = 25 kg/m².
- •Subject weight less than 62 kg.
- •Subject is currently following a weight loss diet.
- •Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
- •Subject has diabetes.
- •Subject has a significant heart, lung, liver or kidney disease.
- •Subject has any history of a neurological disorder.
- •Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
- •Subject has retinopathy.
- •Subject suffers from psoriasis.
- •Subject has porphyria.
- •Subject shows abnormal eating behavior or has an eating disorder.
- •History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
- •History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
- •Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men.
- •Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including recreational use”) of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
- •High caffeine intake (> 4 cups of coffee daily or equivalent).
- •Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
- •Recent participation (<30 days) or simultaneous participation in another clinical study.
- •Subjects with lactose intolerance.
- •Subjects with quinine allergy.
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