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Completed

NCT Number: NCT03143725

Study to Compare Bioavailability of GLPG1972 Given as 2 Different Tablet Formulations Versus an Oral Solution

This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet relative to an oral solution and to the oral direct compression (DC) tablet after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the WG oral tablet.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Belgium Life Sciences

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male between 18 and 50 years of age, inclusive,
  • A body mass index (BMI) between 18-30 kg/m², inclusive, weight of 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 laboratory findings.
  • Discontinuation of all medications except occasional paracetamol at least 2 weeks or 5 half-lives prior to the first study drug administration.
  • Non-smokers and not using any nicotine-containing products.
  • Negative urine drug screen and alcohol breath test.
  • Current sexually active male agrees to use adequate contraception
  • Willing to consume a non-vegetarian high-fat and high-calorie breakfast
  • Able and willing to sign the ICF

Exclusion criteria

  • Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
  • Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
  • History of or a current immunosuppressive condition
  • Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
  • History of malignancy within the past 5 years
  • Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QTcF >450 msec, or a known long QT syndrome).
  • Presence of abnormal liver function
  • Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula.
  • Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
  • Clinically relevant abnormalities detected on "vital signs"
  • Dietary requirements precluding participation.
  • Significant blood loss including blood donation or had a transfusion of any blood product within 12 weeks
  • Hemoglobin level <7.5 mmol/L (12 g/dL).
  • Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
  • Current (2 weeks before screening) and planned uninterrupted consumption of large quantities (> 6 cups) of coffee
  • Administration of an injectable drug within 30 days prior to the initial study drug administration.
  • Concurrent participation, or participation in a drug/device study within 8 weeks or 5 half-lives of the drug or within 6 months for biologicals
  • Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff

Treatment and study plan

GLPG1972

Drug

Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)

Primary outcomes

  1. Assessment of the maximum observed plasma concentration of GLPG1972 after single oral doses

    Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses

    Determine bioavailability of GLPG1972 by assessing PK parameters

  2. Assessment of plasma concentration of GLPG1972 24hrs post-dose after single oral doses

    Time frame: At 24 hours post dose

    Determine bioavailability of GLPG1972 by assessing PK parameters

  3. Assessment of time to achieve the maximal plasma concentration of GLPG1972 after single oral doses

    Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses

    Determine bioavailability of GLPG1972 by assessing PK parameters

  4. Assessment of the last quantifiable plasma concentration of GLPG1972 after single oral doses

    Time frame: on day 1 pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post doses

    Determine bioavailability of GLPG1972 by assessing PK parameters

Secondary outcomes

  1. the number of subjects with adverse events

    Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

    To assess safety and tolerability of GLPG1972 given orally

  2. the number of subjects with abnormal vital signs

    Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

    To assess safety and tolerability of GLPG1972 given orally

  3. the number of subjects with abnormal ECG

    Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

    To assess safety and tolerability of GLPG1972 given orally

  4. the number of subjects with abnormal laboratory assessments

    Time frame: at screening, pre-dose at date 1 and post-dose at 24 and 48 hours

    To assess safety and tolerability of GLPG1972 given orally

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Open-label Study to Compare the Bioavailability of an Oral Wet Granulation Tablet of GLPG1972 Relative to an Oral Solution and to an Oral Direct Compression Tablet After Single-dose Intake in Healthy Subjects, and to Evaluate the Effect of Food on the Bioavailability of an Oral Wet Granulation Tablet.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 8, 2017
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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