Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers

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: NCT03515382
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

The sponsor wants to investigate how well the test medicine is taken up by the body when given alongside two other already approved medicines. This kind of study is known as a drug-drug interaction study. In this case the other medicines are itraconazole and voriconazole.

The sponsor will also look at the safety and tolerability of the test medicine when taken alone, and when taken with the approved medicines.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG1690 Drug: Itraconazole Drug: Voriconazole Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Open-Label, Randomized, Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole and Voriconazole on the Single-Dose Pharmacokinetics of GLPG1690 in Healthy Male Subjects
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A
single dose GLPG1690.
Drug: GLPG1690
A single oral dose of GLPG1690.

Experimental: Treatment B
Single dose itraconazole + single dose GLPG1690.
Drug: GLPG1690
A single oral dose of GLPG1690.

Drug: Itraconazole
A single oral dose of itraconazole.

Experimental: Treatment C
Single dose voriconazole + single dose GLPG1690.
Drug: GLPG1690
A single oral dose of GLPG1690.

Drug: Voriconazole
A single oral dose of voriconazole.




Primary Outcome Measures :
  1. Maximum observed plasma concentration of GLPG1690 (Cmax). [ Time Frame: At various time points between Day 1 pre-dose and Day 5 ]
    To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

  2. Area under the plasma concentration-time curve from time zero to infinity of GLPG1690 (AUC0-∞). [ Time Frame: At various time points between Day 1 pre-dose and Day 5 ]
    To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

  3. Apparent terminal half-life of GLPG1690 (t1/2,λz). [ Time Frame: At various time points between Day 1 pre-dose and Day 5 ]
    To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.


Secondary Outcome Measures :
  1. Number of incidents of TEAEs. [ Time Frame: Between screening and 10 days after the last dose ]
    To assess safety and tolerability of GLPG1690.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written, signed and dated informed consent form (ICF) as approved by the Independent Ethics Committee (IEC), prior to any screening evaluations.
  • Male subject between 18-55 years of age (extremes included) on the day of signing the ICF.
  • Body mass index (BMI) between 18.0-32.0 kg/m², inclusive, with body weight at least 50 kg.
  • Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory results.
  • Non-smoker, defined as an individual who has abstained from smoking (or the use of e-cigarettes or nicotine containing products) from at least 1 year prior to screening. A breath carbon monoxide reading of less than or equal to 10 ppm at screening and admission.
  • Negative urine drug screen (at a minimum: amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) and alcohol breath test at screening and admission.
  • Negative serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis B virus surface antigen (HBs-Ag) or hepatitis C virus antibody (HCV-Ab), or any history of hepatitis from any cause, with the exception of hepatitis A at screening.
  • Subject must agree to use highly effective contraceptive measures as and must be able and willing to comply with the other prohibitions and restrictions as described in the protocol.

Exclusion Criteria:

  • History of serious allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization) and/or known sensitivity to study drug or the excipients.
  • Use of strong inhibitors and/or inducers of CYP3A4/5 and/or P-gp, including consumption of herbal medications (e.g. St. John's Wort) and grapefruit/grapefruit products within 7 days prior to the first study drug administration.
  • Contra-indication for the use of itraconazole or voriconazole as described in the package insert.
  • Abnormal liver function test, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin and/or gamma-glutamyl transferase (GGT) > 1.5 x upper limit of normal (ULN). Retesting is allowed once. Subjects with documented Gilbert's syndrome are eligible for inclusion in the study.
  • History of malignancy within the past 5 years (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
  • Clinically relevant abnormalities detected on ECG regarding either rhythm, rate or conduction (e.g. QT interval corrected for the heart rate using Fridericia's formula [QTcF] ≥450 ms, or a known long QT syndrome). A first degree heart block or sinus arrhythmia is not considered as a significant abnormality.
  • Clinically relevant abnormal vital signs and/or abnormalities detected during physical examination.
  • Per judgment of the investigator, substantial blood loss (including blood donation), or a transfusion of any blood product within 8 weeks prior to the first study drug administration.
  • Any condition or circumstances that, in the opinion of the investigator, could make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

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): NCT03515382


Locations
Layout table for location information
United Kingdom
Quotient Sciences Limited
Ruddington, United Kingdom
Sponsors and Collaborators
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Christopher Brearley, BM, MRCP, MFPM Galapagos NV

Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03515382     History of Changes
Other Study ID Numbers: GLPG1690-CL-106
2017-004357-16 ( EudraCT Number )
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Itraconazole
Hydroxyitraconazole
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors