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CompletedNCT03515382Updated Jun 11, 2018

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

A Phase 1 interventional study of GLPG1690 and Itraconazole in Healthy, sponsored by Galapagos NV. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.

Sponsored by Galapagos NV · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Galapagos NV is the lead sponsor of 103 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Treatment A

    single dose GLPG1690.

    Drug: GLPG1690

  • Experimental
    Treatment B

    Single dose itraconazole + single dose GLPG1690.

    Drug: GLPG1690 · Drug: Itraconazole

  • Experimental
    Treatment C

    Single dose voriconazole + single dose GLPG1690.

    Drug: GLPG1690 · Drug: Voriconazole

Interventions

  • DrugGLPG1690

    A single oral dose of GLPG1690.

  • DrugItraconazole

    A single oral dose of itraconazole.

  • DrugVoriconazole

    A single oral dose of voriconazole.

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration of GLPG1690 (Cmax).

    To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

    Time frame: At various time points between Day 1 pre-dose and Day 5

  2. Area under the plasma concentration-time curve from time zero to infinity of GLPG1690 (AUC0-∞).

    To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

    Time frame: At various time points between Day 1 pre-dose and Day 5

  3. Apparent terminal half-life of GLPG1690 (t1/2,λz).

    To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.

    Time frame: At various time points between Day 1 pre-dose and Day 5

Secondary outcomes

  1. Number of incidents of TEAEs.

    To assess safety and tolerability of GLPG1690.

    Time frame: Between screening and 10 days after the last dose

07

Study locations

1 site
  • Quotient Sciences Limited
    Ruddington, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03515382
Lead sponsor
Galapagos NV
Responsible party
Sponsor
First posted
May 3, 2018
Start date
Mar 16, 2018
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Jun 11, 2018

Study contacts

Christopher Brearley, BM, MRCP, MFPM
study director · Galapagos NV

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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