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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pirfenidone; Drug: Nintedanib; Drug: GLPG4716

• Registration Number: NCT04971746
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-19
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GLPG4716 and nintedanib	Nintedanib	-
GLPG4716 and pirfenidone	GLPG4716	-
GLPG4716 and nintedanib	GLPG4716	-
GLPG4716 and pirfenidone	Pirfenidone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	To evaluate the safety and tolerability of GLPG4716 alone or when co-administered with pirfenidone or nintedanib.

Trial Locations

Locations (1)

Nuvisan GmbH; 🇩🇪 Neu-Ulm, Germany