Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04971746 | Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects | PHASE1 | COMPLETED | 58 | — | — | Jul 19, 2021 | May 9, 2022 | Sep 19, 2024 | 1 | Germany |
To determine the effect of GLPG4716 on the PK of pirfenidone
To determine the effect of GLPG4716 on the PK of pirfenidone
To determine the effect of GLPG4716 on the PK of nintedanib.
To determine the effect of GLPG4716 on the PK of nintedanib.
| Arm | Type | Description |
|---|---|---|
| GLPG4716 and pirfenidone | EXPERIMENTAL | - |
| GLPG4716 and nintedanib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pirfenidone | DRUG | On Days 1 and 13, participants will receive an oral dose of pirfenidone. |
| GLPG4716 | DRUG | From Day 3 to Day 14, participants will receive GLPG4716 daily. |
| Nintedanib | DRUG | On Days 1 and 13, participants will receive an oral dose of nintedanib. |
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 b...