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CompletedNCT04137341Updated Jan 13, 2020

A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines

A Phase 1 interventional study of GLPG1972 - A and GLPG1972 - B 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 2020-01-13.

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 two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.

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

  • Male between 18-55 years of age (extremes included), on the date of signing the informed consent form
  • A body mass index (BMI) between 18.0-30.0 kg/m2, inclusive
  • Judged to be in good health by the investigator based upon the results of medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator
  • Subject must be able and willing to comply with restrictions on prior medication as described in the protocol
  • Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to the investigational medicinal product (IMP) ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hay fever is allowed unless active.
  • Positive serology for hepatitis B virus surface antigen or hepatitis C virus or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first IMP administration.
  • History of or a current immunosuppressive condition (e.g. human immunodeficiency virus infection)
  • Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first IMP administration.
  • Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min, using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min, a 24-hour urine collection can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
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
    Tablet A

    A single oral 300-mg dose of GLPG1972 in fasted state

    Drug: GLPG1972 - A

  • Experimental
    Tablet B

    A single oral 300-mg dose of GLPG1972 in fasted state

    Drug: GLPG1972 - B

  • Experimental
    Tablet C

    A single oral 300-mg dose of GLPG1972 in fasted state

    Drug: GLPG1972 - C

  • Experimental
    Food effect

    selected tablet B or C under fed conditions

    Drug: GLPG1972 - B · Drug: GLPG1972 - C

Interventions

  • DrugGLPG1972 - A

    Film-coated tablet, formulation A

  • DrugGLPG1972 - B

    Film-coated tablet, formulation B

  • DrugGLPG1972 - C

    Film-coated tablet, formulation C

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between tablet formulations

    To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972

    Time frame: From Day 1 pre-dose up to Day 4

  2. Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between tablet formulations

    To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972

    Time frame: From Day 1 pre-dose up to Day 4

  3. Maximum observed plasma concentration (Cmax) ratio between tablet formulations

    To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972

    Time frame: From Day 1 pre-dose up to Day 4

  4. Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between fed and fasted

    To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972

    Time frame: From Day 1 pre-dose up to Day 4

  5. Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between fed and fasted

    To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972

    Time frame: From Day 1 pre-dose up to Day 4

  6. Maximum observed plasma concentration (Cmax) ratio between fed and fasted

    To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972

    Time frame: From Day 1 pre-dose up to Day 4

Secondary outcomes

  1. The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations

    To evaluate the safety and tolerability of oral doses of GLPG1972 tablet formulations

    Time frame: From Day 1 through study completion, an average of 2 months

07

Study locations

1 site
  • Quotient Sciences Limited
    Nottingham, NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04137341
Lead sponsor
Galapagos NV
Responsible party
Sponsor
First posted
Oct 24, 2019
Start date
Oct 9, 2019
Primary completion
Dec 13, 2019
Completion
Dec 13, 2019
Last update
Jan 13, 2020

Study contacts

Angela de Haas-Amatsaleh, MD
study director · Galapagos NV

Oversight

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

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