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

• ClinicalTrials.gov Identifier: NCT04971746
• Recruitment Status: Completed
• First Posted: July 21, 2021
• Last Update Posted: June 2, 2022
• Sponsor: Galapagos NV
• Information provided by (Responsible Party): Galapagos NV

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Pirfenidone; Drug: GLPG4716; Drug: Nintedanib	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: July 19, 2021
• Actual Primary Completion Date: May 9, 2022
• Actual Study Completion Date: May 9, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: GLPG4716 and pirfenidone	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.
Experimental: GLPG4716 and nintedanib	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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. Cmax of nintedanib [ Time Frame: From Day 1 pre-dose until Day 15 ]
   To determine the effect of GLPG4716 on the PK of nintedanib.
4. 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 Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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.

Contacts and Locations

Locations

Germany

Nuvisan GmbH

Neu-Ulm, Germany, 89231

Sponsors and Collaborators

Galapagos NV

Investigators

• Study Director: Natalia Rueda-Rincon, MD; Galapagos NV

More Information

• Responsible Party: Galapagos NV
• ClinicalTrials.gov Identifier: NCT04971746
• Other Study ID Numbers: GLPG4716-CL-101; 2021-001718-12 ( EudraCT Number )
• First Posted: July 21, 2021
• Last Update Posted: June 2, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pirfenidone; Nintedanib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents