A PHASE 1, OPEN LABEL, SINGLE DOSE, 4TREATMENT, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF DIFFERENT MEAL REGIMENS AND THE EFFECT OF PROLONGED GASTRIC ACID SUPPRESSION BY RABEPRAZOLE ON THE RELATIVE ORAL BIOAVAILABILITY OF DERAZANTINIB IN HEALTHY MALE SUBJECTS - Derazantinib food effect and proton pump inhibitor study

Basilea Pharmaceutica International Ltd0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年4月15日

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•1. Able to communicate well with the Investigator, and able to understand and
•comply with the requirements of the study. He should also be able to understand
•and sign the ICF.
•2. Has signed the ICF prior to initiation of any studyspecific procedures.
•3. Male subjects between 18 and 55 years of age, inclusive, having a body mass
•index within the range of 18.0 kg/m2 to 29.0 kg/m2, inclusive, and weighing at
•least 50 kg at screening.
•4. In good health as determined by medical history, physical examination, vital
•signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests (clinical
•chemistry, hematology, and urinalysis) at screening.
•5. Supine vital signs within the following ranges at screening:
•Systolic blood pressure: 90 mmHg to 140 mmHg, inclusive
•Diastolic blood pressure: 50 mmHg to 90 mmHg, inclusive
•Pulse rate: 40 bpm to 90 bpm, inclusive
•Body temperature: 35.5°C to 37.6°C, inclusive
•When measuring standing vital signs, there should be no more than a 20 mmHg
•decrease in systolic blood pressure or 10 mmHg decrease in diastolic blood
•pressure as this is an indication of postural hypotension. Any subject
•exhibiting clinical manifestations of postural hypotension should be excluded.

•1. Previous participation in the current study.
•2. Employee of PRA or the Sponsor.
•3. Legal incapacity or limited legal capacity at screening.
•4. History of hypersensitivity to any of the study drugs or to drugs of similar
•chemical classes, or history of relevant drug and/or food allergies.
•5. Known hypersensitivity or allergy to natural rubber latex.

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