The primary objective is to investigate safety and tolerability of BI 1015550 in patients with IPF. The secondary objectives are to evaluate the pharmacokinetics (PK) of BI 1015550 in patients with IPF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
3 tablets of 6 milligram (mg) of BI 101550 (total: 18 mg) were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily (bid).
3 tablets of Placebo, matching in size and weight to BI 1015550 6 milligram (mg) tablet, were administrated as an oral dose together with about 240 milliliter (mL) of water twice daily.
Odense University Hospital
Odense, Denmark
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, Finland
TYKS
Turku, Finland
Fraunhofer ITEM
Percentage of Participants With Drug-related Adverse Events (AEs) On-treatment
The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). All AEs which occurred through the treatment phase and throughout the residual effect period (REP) were considered as on treatment. Treatment period was 4 weeks for patients entered after approval of a global protocol amendment at 12 Feb 2019 or 12 weeks for those entered before approval.
Time frame: From first dose until last dose of treatment period (duration depends on the time a patient entered the trial) + 7 days of REP or until patient's trial termination date, whichever occurred earlier, up to 35 or 91 days.
Area Under the Concentration-time Curve (AUCτ,1) of the BI 1015550 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose on Day 1
Area under the concentration-time curve (AUCτ,1) of the BI 1015550 in plasma over a uniform dosing interval τ after administration of the first dose on Day 1.
Time frame: On Day 1, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.
Maximum Measured Concentration (Cmax) of the BI 1015550 in Plasma on Day 1
Maximum measured concentration (Cmax) of the BI 1015550 in plasma on Day 1.
Time frame: On Day 1, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.
Area Under the Concentration-time Curve (AUCτ,ss) of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval τ on Day 14
Area under the concentration-time curve (AUCτ,ss) of the BI 1015550 in plasma at steady state over a uniform dosing interval τ on Day 14.
Time frame: On Day 14, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.
Maximum Measured Concentration (Cmax,ss) of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval τ on Day 14
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Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Poli Univ A. Gemelli
Roma, Italy
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Hospital de Bellvitge
L'Hospitalet de Llobregat, Spain
Royal Brompton Hospital
London, United Kingdom
...and 1 more locations
Maximum measured concentration (Cmax,ss) of the BI 1015550 in plasma at steady state over a uniform dosing interval τ on Day 14.
Time frame: On Day 14, within 2 hours before morning dose and at 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after morning dose.