An open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous [14C] OZ439 microdose/800 mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a string CYP3A4 inhibitor, to healthy subjects in fasted state - Absolute BA PK of OZ439 volumes and cobicistat co-administration study

Medicines for Malaria Venture0 个研究点目标入组 26 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•- the volunteer is willing to participate in this study
•- the volunteer isa healthy male or female
•- the female volunteers must be of non-childbearing potential (either surgically sterilized or postmenopausal)
•- the volunteer is between 18 and 55 years of age, inclusive
•- the volunteer has a BMI is between 18.0 and 30.0 kilograms/meter2
•- the volunteer does not smoke or you smoke no more than 5 cigarettes per day (or comparable amount of cigars or pipe), and the volunteer is able to abstain from smoking from entry into the clinical research center and during his/herstay in the clinical research center
•- at the pre-study screening the volunteers state of health must satisfy the study entry requirements

•Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study. Donation or loss of more than 100 mL of blood within 90 days prior to drug administration.

发起方

Medicines for Malaria Venture