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

Overview

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.

Full Title of Study: “An Open-label, Fixed-sequence Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Nintedanib and Pirfenidone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

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.

Arms, Groups and Cohorts

  • Experimental: GLPG4716 and pirfenidone
  • Experimental: GLPG4716 and nintedanib

Clinical Trial Outcome Measures

Primary Measures

  • Maximum observed plasma concentration (Cmax) of pirfenidone
    • Time Frame: 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
    • Time Frame: From Day 1 pre-dose until Day 15
    • To determine the effect of GLPG4716 on the PK of pirfenidone
  • Cmax of nintedanib
    • Time Frame: From Day 1 pre-dose until Day 15
    • To determine the effect of GLPG4716 on the PK of nintedanib.
  • AUC0-inf of nintedanib
    • Time Frame: From Day 1 pre-dose until Day 15
    • To determine the effect of GLPG4716 on the PK of nintedanib.

Secondary Measures

  • Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
    • Time Frame: 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.

Participating in This Clinical Trial

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 exclusion criteria.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Galapagos NV
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Natalia Rueda-Rincon, MD, Study Director, Galapagos NV
  • Overall Contact(s)
    • Galapagos Medical Information, +3215342900, medicalinfo@glpg.com

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