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Recruiting
NCT05668741
A Phase 1 Study of VX-522 in Participants With Cystic Fibrosis (CF)
Conditions: Cystic Fibrosis
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE1
Enrollment: 9
Sponsor: Vertex Pharmaceuticals Incorporated
Location: United States
Summary
The purpose of this study is to evaluate the safety and tolerability of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
Eligibility Criteria
Key Inclusion Criteria:Body mass index (BMI) of greater than or equal to (≥)18.0 to less than (<) 30.0 kilograms per meter square (kg/m^2)A total body weight greater than (>) 50 kgStable CF diseaseCFTR gene mutations on both alleles that are not responsive to CFTR modulator therapyForced expiratory volume in 1 second (FEV1) value, percent of predicted mean for age, sex, and height (equations of the Global Lung Function Initiative [GLI])18 ≥40%Key Exclusion Criteria:History of uncontrolled asthma within a year prior to screeningHistory of solid organ or hematological transplantationHepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)Arterial oxygen saturation on room air less than (<) 94% at screeningOther protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05668741). StuddyBuddy aggregates publicly available trial information.