Healthy
Conditions
Brief summary
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.
Interventions
DRUGPirfenidone
On Days 1 and 13, participants will receive an oral dose of pirfenidone.
DRUGGLPG4716
From Day 3 to Day 14, participants will receive GLPG4716 daily.
DRUGNintedanib
On Days 1 and 13, participants will receive an oral dose of nintedanib.
Sponsors
Galapagos NV
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Female subjects should be of non-childbearing potential. * A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate transaminase and alanine aminotransferase must be no greater than the upper limit of normal (ULN). Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator This list only includes the key inclusion criteria.
Exclusion criteria
* Known hypersensitivity to ingredients of GLPG4716, pirfenidone, or nintedanib or history of a significant allergic reaction to ingredients of GLPG4716, pirfenidone, or nintedanib as determined by the investigator. * Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing. This list only includes the key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of pirfenidone | From Day 1 pre-dose until Day 15 | To determine the effect of GLPG4716 on the PK of pirfenidone |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of pirfenidone | From Day 1 pre-dose until Day 15 | To determine the effect of GLPG4716 on the PK of pirfenidone |
| Cmax of nintedanib | From Day 1 pre-dose until Day 15 | To determine the effect of GLPG4716 on the PK of nintedanib. |
| AUC0-inf of nintedanib | From Day 1 pre-dose until Day 15 | To determine the effect of GLPG4716 on the PK of nintedanib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations. | From Day 1 through study completion, an average of 2 months | To evaluate the safety and tolerability of GLPG4716 alone or when co-administered with pirfenidone or nintedanib. |
Countries
Germany
Outcome results
None listed