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Recruiting Phase 1/2 NCT05668741

A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)

Phase 1/2 – combined early trial
Conditions: Cystic Fibrosis

Sponsor: Vertex Pharmaceuticals Incorporated

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety, and tolerability and efficacy 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.
Who can participate
Key Inclusion Criteria: * Body mass index is less than (\<) 30.0 kilograms per meter square (kg/m\^2) * A total body weight greater than (\>) 50 kg * Stable CF disease * CFTR gene mutations on both alleles that are not responsive to CFTR modulator therapy o Example mutations include but are not limited to, mutations that do not produce CFTR protein (i.e., Class I): nonsense mutations (e.g., G542X, W1282X) and canonical splice mutations (e.g., 621+1G-\>T) * Forced expiratory volume in 1 second (FEV1) value for SAD: greater than or equal to (≥)40 percent (%), MAD: ≥ 50% to less than or equal to (≤) 90% Key Exclusion Criteria: * History of uncontrolled asthma within a year prior to screening * History of solid organ or hematological transplantation * Hepatic 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 screening Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 10
Australia (1)
The Alfred Hospital - Pulmonology
Melbourne
Belgium (1)
Universitair Ziekenhuis Gent
Ghent
Canada (1)
University of Calgary Medical Clinic of the Foothills Medical Centre
Calgary
Germany (1)
Ruhrlandklinik
Essen
Italy (1)
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico - Pulmonology
Genova
Netherlands (1)
UMCU - Department of Pulmonology and Tuberculosis
Utrecht
WITHDRAWN
Spain (1)
Hospital Universitari Vall d´Hebron Servicio de Broncoscopia
Barcelona
Sweden (1)
Karolinska University Hospital - Pulmonology
Stockholm
United Kingdom (1)
Papworth Hospital NHS Foundation Trust
Cambridge
COMPLETED
United States (1)
University of Alabama at Birmingham - Child Health Research Unit
Birmingham , Alabama
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
27.02.2023
Completion date
12.05.2027
Registry ID
NCT05668741
Source
anzctr
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