Projektdaten
A randomised, double-blind, placebo-controlled, parallel group trial evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of BI 1291583 one tablet once daily over 12 weeks versus placebo in adult patients with cystic fibrosis bronchiectasis (ClairaflyTM)
Hochschule
Universitätsklinikum Jena
Fakultät/Einrichtung
Medizinische Fakultät
Förderkategorie
Auftragsforschung
Zeitraum
2024 - 2025
Drittmittelgeber
Boehringer Ingelheim Pharma GmbH & Co. KG
Stichwort
Bewilligungssumme, Auftragssumme
Kategorie 10.000,00 - 99.999,00 €
Abstract:
Primary objective: To investigate safety and tolerability of 5 mg BI 1291583 in patients with CFB following oral daily administration over 12 weeks.Secondary objectives: To investigate pharmacodynamics (PD) and to assess the PK after the first dose and at steady state after multiple dosing of BI 1291583 5 mg qd