Phase 1 Integrated Randomized Open-Label Formulation Selection and Food Effect Assessment Study of MAX-001 in Healthy Subjects

George Clinical Pty Ltd0 个研究点目标入组 34 人开始时间: 2022年10月20日最近更新: 2024年7月22日

适应症

试验速览

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•Able to understand, sign, and commit to informed consent and to all study procedures
•- Adhere to effective double-barrier contraception or in proven post-menopause
•- Healthy as determined during screening based on medical history, physical examination, vital signs, ECG (QTcF <=450 msec in males, QTcF <=470 in females), and laboratory assessments
•- Body Mass Index 18 to 32.0 kg/m2
•- Non-smokers or social smokers (0-5 cigarettes per month)
•- Commitment to adhere to lifestyle guidance during the study participation

•- Any lifetime antecedent, any disease or medication indicative of past seizures, epilepsy, or any disease or medication that increases the risk of seizures
•- Any antecedent of ischemic heart disease, angina, QTcF > 450 msec in males and > 470 msec in females, QRS prolongation, arrhythmia, and prior occurrence of torsades de pointe, as well as absence of family history of long QT syndrome or sudden cardiac death
•- Any antidepressant use, such as a monoamine oxidase inhibitor like phenelzine, a tricyclic antidepressant such as amitriptyline or nortryptiline, or a single-, double-, or triple monoamine reuptake inhibitor (SSRI, SNRI, SNDRI)
•- Use of drowsiness-causing antihistaminics
•- Serology indicative of HIV or hepatitis B or C
•- Abnormal liver function tests
•- Abnormal renal function tests as assessed by the creatinine clearance
•- Past or current cancer and its treatment
•- Glaucoma
•- Substance use disorder in medical history, urine drug screen and alcohol breath test
•- Mental health disorder diagnosis and/or treatment
•- Pregnancy or breastfeeding

发起方