Skip to main content
OpenTrials
Completed

NCT Number: NCT03143712

Study to Assess Bioavailability of GLPG1690 Given as Oral Capsule or Tablet

This study is a Phase I, randomized, open-label, cross-over study with three single-dose treatments to compare the bioavailability of an oral tablet relative to an oral capsule of GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food on the bioavailability of the oral tablet.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS CPU

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male between 18-50 years of age, inclusive
  • Body mass index (BMI) between 18-30 kg/m2, inclusive, with a 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/preventive exposure measures from the time of first dose of study drug, during the study and until 12 weeks after the last study drug dose.
  • Subjects should be willing to consume the 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.
  • Presence of abnormal liver function. Diagnosis of disease of Gilbert is accepted. Retesting is allowed.
  • Renal function with an estimated creatinine clearance <80 ml/min based on the Cockcroft-Gault formula. Retesting is allowed.
  • Presence of any condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
  • History of malignancy within the past 5 years
  • Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF >450 ms, or a known long QT syndrome).
  • Clinically relevant abnormalities detected on vital signs.
  • Dietary requirements precluding participation in the study
  • Significant blood loss (including blood donation [≥450 mL]), or transfusion of any blood product within 8 weeks prior to the signing of ICF.
  • Active drug or alcohol abuse within 2 years prior to the initial study drug administration.
  • Consumption of large quantities of caffeinated coffee or tea (>6 cups/day), or equivalent.
  • Concurrent participation or participation in a drug or drug/device investigational research study.
  • Subjects who participated in a previous study with the same compound (GLPG1690).
  • Investigator or any sub-investigator, or other staff or relative.
  • Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.

Treatment and study plan

GLPG1690

Drug

Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)

Primary outcomes

  1. Assessment of the maximum observed plasma concentration of GLPG1690 after single oral doses

    Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing

    Determine the bioavailability of GLPG1690 by assessing PK parameters

  2. Assessment of the time to reach the maximum observed plasma concentration of GLPG1690 after single oral doses

    Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing

    Determine the bioavialability of GLPG1690 by assessing PK parameters

  3. Assessment of the time of the last quantifiable plasma concentration of GLPG1690 after single oral doses

    Time frame: predose at day 1 and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post dosing

    Determine the bioavialability of GLPG1690 by assessing PK parameters

Secondary outcomes

  1. The number of subjects with adverse events

    Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)

    To assess safety and tolerability of GLPG1690

  2. The number of subjects with abnormal vital signs

    Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)

    To assess safety and tolerability of GLPG1690

  3. The number of subjects with abnormal ECG

    Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)

    To assess safety and tolerability of GLPG1690

  4. The number of subjects with abnormal physical examination

    Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)

    To assess safety and tolerability of GLPG1690

  5. The number of subjects with abnormal laboratory analysis

    Time frame: Throughout the study from screening until the follow up visit (day 7 of dosing period 3)

    To assess safety and tolerability of GLPG1690

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

An Open Label Study to Compare the Oral Bioavailability of a Tablet of GLPG1690 Relative to a Capsule After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the 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.

Published trials that share one or more normalized conditions with this study.