A phase I, single-dose, randomized, crossover, relative bioavailability and food-effect study and phase I, single-dose, fixed-sequence, crossover, pH-effect study of belvarafenib (GDC-5573) in healthy subjects

F. Hoffmann-La Roche Ltd0 个研究点目标入组 66 人开始时间: 2022年9月20日最近更新: 2024年3月11日

适应症

试验速览

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•1. Males or females of non-childbearing potential, between 18 and 65 years of age, inclusive
•2. Within body mass index (BMI) range 18 to 32 kilograms per square meter (kg/m^2), inclusive, at Screening
•3. Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile. For all females, the pregnancy test result must be negative at Screening and Period 1 Check-in (Day -1)
•4. Negative screening test for latent Mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold. Indeterminate results may be confirmed by repeat or by a purified protein derivative (PPD) skin test

•1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
•2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that uncomplicated appendectomy and hernia repair will be allowed
•3. History of acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) as determined by the investigator (or designee) at Screening or Period 1 Check-in (Day -1)
•4. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 90 days, whichever is longer, prior to study entry
•5. Treatment with intravenous antibiotics within 8 weeks or oral antibiotics within 4 weeks prior to Screening or during the entire study duration
•6. Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A, and for Cohort 2b CYP2C19, within 30 days prior to Period 1 Check-in (Day -1) and during the entire study duration
•7. Poor peripheral venous access
•8. History of malignancy within 5 years prior to enrollment

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