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Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects

NCT04971746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Pirfenidone

On Days 1 and 13, participants will receive an oral dose of pirfenidone.

DRUG

GLPG4716

From Day 3 to Day 14, participants will receive GLPG4716 daily.

DRUG

Nintedanib

On Days 1 and 13, participants will receive an oral dose of nintedanib.

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Natalia Rueda-Rincon, MD · Galapagos NV

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-05-09
Completion
2022-05-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971746 on ClinicalTrials.gov