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

NCT ID: NCT04971746

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2022-05-09

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

GLPG4716 and pirfenidone

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: DRUG

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

GLPG4716

Intervention Type: DRUG

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

GLPG4716 and nintedanib

Group Type: EXPERIMENTAL

GLPG4716

Intervention Type: DRUG

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

Nintedanib

Intervention Type: DRUG

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

Interventions

Pirfenidone

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

Intervention Type: DRUG

GLPG4716

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

Intervention Type: DRUG

Nintedanib

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

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Rueda-Rincon, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Nuvisan GmbH

Neu-Ulm, , Germany

Countries

Germany

Other Identifiers

2021-001718-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG4716-CL-101

Identifier Type: -

Identifier Source: org_study_id