Experimental hypothermia using cold ambient temperature and drug-induced inhibition of shivering in awake, healthy volunteers: a crossover, double blinded trial

Helse Bergen HF0 个研究点目标入组 16 人开始时间: 2023年6月28日最近更新: 2024年7月22日

适应症

试验速览

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•Participant must be over 18 and under 40 years of age at the time of signing the informed consent., Participants who are overtly healthy as determined by their medical history. The participants will be asked to fill out a health-report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the IMPs used., BMI under 30 kg/m2, Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and 2., Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

•Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidin, klorpromazine, fenytoin, erythromycin, itrakonazol, platelet inhibitors, apomorfin, alcohol (during the trial period) or other opioids (during the trial period). A history of drug dependency., Recent head injury, increased ICP, seizures or epilepsy., Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, Myasthenia gravis. Previous abdominal surgery. History of cold injuries or frostbites., Planned MRI the next two days after ingestion of temperature capsule.

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