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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04971746
Recruitment Status : Completed
First Posted : July 21, 2021
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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.




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.



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971746


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Natalia Rueda-Rincon, MD Galapagos NV
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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    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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