The main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
58
On Days 1 and 13, participants will receive an oral dose of pirfenidone.
From Day 3 to Day 14, participants will receive GLPG4716 daily.
On Days 1 and 13, participants will receive an oral dose of nintedanib.
Nuvisan GmbH
Neu-Ulm, Germany
Maximum observed plasma concentration (Cmax) of pirfenidone
To determine the effect of GLPG4716 on the PK of pirfenidone
Time frame: From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of pirfenidone
To determine the effect of GLPG4716 on the PK of pirfenidone
Time frame: From Day 1 pre-dose until Day 15
Cmax of nintedanib
To determine the effect of GLPG4716 on the PK of nintedanib.
Time frame: From Day 1 pre-dose until Day 15
AUC0-inf of nintedanib
To determine the effect of GLPG4716 on the PK of nintedanib.
Time frame: From Day 1 pre-dose until Day 15
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
To evaluate the safety and tolerability of GLPG4716 alone or when co-administered with pirfenidone or nintedanib.
Time frame: From Day 1 through study completion, an average of 2 months
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