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Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis
Sponsor: Redx Pharma Ltd
Summary
The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12 weeks (84 days), alone and in combination with nintedanib or pirfenidone.
Official title: A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients With Idiopathic Pulmonary Fibrosis
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2022-09-08
Completion Date
2025-01-09
Last Updated
2024-08-23
Healthy Volunteers
No
Interventions
RXC007
RXC007 will be administered in the form of oral capsules at 3 potential dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and the Expansion cohort will receive RXC007. The Dosage regimen is BID or QD.
Placebo
The placebo will be administered in the form of oral capsules at each dose level to 4 of the 16 participants within cohorts 1, 2 and the Expansion cohort. The Dosage regimen is BID or QD
Locations (31)
Medical University of Vienna
Vienna, Austria
E PNE UZ Leuven
Leuven, Belgium
CHU De Liège
Liège, Belgium
Pneumologicka klinika 1.LF UK a
Prague, Czechia
Azienda Ospedaliero-Universitaria "Ospedali-Riuniti" di Ancona
Ancona, Italy
Azienda Ospedaliero Universitaria Policlinico ''G.Rodolico-San Marco''
Catania, Italy
Colonello D'avanzo Hospital
Foggia, Italy
PO Vito Fazzi
Lecce, Italy
Ospedale S. Giuseppe Milano
Milan, Italy
Azienda Ospedaliera Universitaria of Modena
Modena, Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
University Clinical Centre in Gdansk
Gdansk, Poland
Barlicki University Hospital
Lodz, Poland
Institute of Tuberculosis and Lung Diseases in Warsaw
Warsaw, Poland
Policlinica Barcelona
Barcelona, Spain
Hospital Universitario Clínic de Barcelona
Barcelona, Spain
L'Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
University Hospital of Geneve
Geneva, Switzerland
Belfast City Hospital
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Papworth Hospital NHSFT
Cambridge, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Guy's Hospital
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Altnagelvin Area Hospital
Londonderry, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, United Kingdom