A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Granule Formulation of Tezacaftor and Ivacaftor Compared to a Fixed-dose Combination Tablet in Healthy Adult Subjects

Vertex Pharmaceuticals Incorporated0 个研究点目标入组 16 人开始时间: 2020年2月25日最近更新: 2024年9月9日

适应症

试验速览

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•1. Subject will sign and date an informed consent form (ICF)
•2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures
•3. Subjects (male and female) between the ages of 19 and 55 years, inclusive, and healthy, as defined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination (PE), including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
•4. Body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive, and a total body weight >50 kg
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. History of febrile illness or other acute illness within 5 days before the first study drug dose
•2. Any condition possibly affecting drug absorption
•3. History of, or positive screen for, hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2)
•4. History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
•5. Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug

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