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

NCT04971746 | Completed Phase 1

• 2 other identifiers: GLPG4716-CL-1012021-001718-12
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Maximum observed plasma concentration (Cmax) of pirfenidone

  To determine the effect of GLPG4716 on the PK of pirfenidone

  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

  From Day 1 pre-dose until Day 15

• Cmax of nintedanib

  To determine the effect of GLPG4716 on the PK of nintedanib.

  From Day 1 pre-dose until Day 15

• AUC0-inf of nintedanib

  To determine the effect of GLPG4716 on the PK of nintedanib.

  From Day 1 pre-dose until Day 15

Secondary Outcomes (1)

• 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

Study Arms (2)

GLPG4716 and pirfenidone

EXPERIMENTAL

Drug: Pirfenidone; Drug: GLPG4716

GLPG4716 and nintedanib

EXPERIMENTAL

Drug: GLPG4716; Drug: Nintedanib

Interventions

Pirfenidone DRUG

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

GLPG4716 and pirfenidone

GLPG4716 DRUG

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

GLPG4716 and nintedanib; GLPG4716 and pirfenidone

Nintedanib DRUG

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

GLPG4716 and nintedanib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Interventions

pirfenidone; nintedanib

Study Officials

• Natalia Rueda-Rincon, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 21, 2021
• Study Start: July 19, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: September 19, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)