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

NCT03143712 | Completed Phase 1

• 1 other identifier: GLPG1690-CL-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  Determine the bioavailability of GLPG1690 by assessing PK parameters

  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

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

  Determine the bioavialability of GLPG1690 by assessing PK parameters

  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

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

  Determine the bioavialability of GLPG1690 by assessing PK parameters

  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

Secondary Outcomes (5)

• The number of subjects with adverse events

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

• The number of subjects with abnormal vital signs

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

• The number of subjects with abnormal ECG

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

• The number of subjects with abnormal physical examination

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

• The number of subjects with abnormal laboratory analysis

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

Study Arms (3)

Treatment A

EXPERIMENTAL

GLPG1690 oral capsules after breakfast

Drug: GLPG1690

Treatment B

EXPERIMENTAL

GLPG1690 oral tablets after breakfast

Drug: GLPG1690

Treatment C

EXPERIMENTAL

GLPG1690 oral tablets after overnight fast

Drug: GLPG1690

Interventions

GLPG1690 DRUG

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

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS CPU

Antwerp, Belgium

Location

Related Publications (1)

• van der Aar E, Desrivot J, Dupont S, Heckmann B, Fieuw A, Stutvoet S, Fagard L, Van de Wal K, Helmer E. Safety, Pharmacokinetics, and Pharmacodynamics of the Autotaxin Inhibitor GLPG1690 in Healthy Subjects: Phase 1 Randomized Trials. J Clin Pharmacol. 2019 Oct;59(10):1366-1378. doi: 10.1002/jcph.1424. Epub 2019 Apr 23.

  PMID: 31012984 DERIVED

MeSH Terms

Interventions

GLPG1690

Study Officials

• Ann Fieuw, MD MSc

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: April 18, 2017
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

BE (1)