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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971746
• Other study ID #: GLPG4716-CL-101
• Secondary ID: 2021-001718-12
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: June 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Pirfenidone
On Days 1 and 13, participants will receive an oral dose of pirfenidone.
• GLPG4716
From Day 3 to Day 14, participants will receive GLPG4716 daily.
• Nintedanib
On Days 1 and 13, participants will receive an oral dose of nintedanib.

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cmax of nintedanib	To determine the effect of GLPG4716 on the PK of nintedanib.	From Day 1 pre-dose until Day 15
Primary	AUC0-inf of nintedanib	To determine the effect of GLPG4716 on the PK of nintedanib.	From Day 1 pre-dose until Day 15
Secondary	Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.	To evaluate the safety and tolerability of GLPG4716 alone or when co-administered with pirfenidone or nintedanib.	From Day 1 through study completion, an average of 2 months