Safety and Efficacy of VX-828/Deutivacaftor Combination Therapy With and Without Tezacaftor in Subjects With Cystic Fibrosis

You likely can't join if

• 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. This includes, but is not limited to, the following: • Liver disease with cirrhosis or portal hypertension. • Solid organ or hematological transplantation. • Alcohol or drug abuse in the past year, including, but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator. • Cancer, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the last 5 years).
• Ongoing or prior participation in a study of an investigational treatment with the exception of the following: • For prospective subjects with ongoing or prior participation in an investigational study of a Vertex CFTR modulator, a washout period of 28 days or 5 terminal half-lives (whichever is longer) must elapse before Day 1. • For prospective subjects with ongoing or prior participation in all other interventional studies, a washout period of 28 days or 5 terminal half-lives (whichever is longer) must elapse before screening. The duration of the elapsed time may be longer if required by local regulations. • Ongoing participation in a noninterventional study (including observational studies and studies requiring assessments without administration of study drug or assignment to other interventions) is permitted.
• Use of prohibited medications as defined in Table 9 4, within the specified window before the first dose of study drug.
• History of intolerance to study drug that would pose an additional risk to the subject in the opinion of the investigator (e.g., subjects with a history of liver function test [LFT] elevations requiring treatment interruption or discontinuation, allergy or hypersensitivity to the study drug).
• Risk factors for Torsade de Pointes and other ventricular arrhythmias, including but not limited to, history of any of the following: familial long QT syndrome, chronic hypokalemia, heart failure, left ventricular hypertrophy, chronic bradycardia, myocardial infarction, cardiomyopathy, arrhythmia (ventricular or atrial fibrillation), acute neurologic events (subarachnoid hemorrhage, intracranial hemorrhage, cerebrovascular accident, or intracranial trauma), or autonomic neuropathy.
• Any of the following abnormal laboratory values at screening: • Total bilirubin ≥2 × upper limit of normal (ULN) • Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) ≥3 × ULN • Hemoglobin <10 g/dL • Abnormal renal function defined as glomerular filtration rate ≤50 mL/min/1.73 m2 (based on the Modified Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation without the race adjustment).