First-in-Human Single and Multiple Dose of GLPG1690

NCT02179502 | Completed Phase 1

• 2 other identifiers: GLPG1690-CL-1012014-000981-23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo. The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of subjects with adverse events

  To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events

  Between screening and 7-10 days after the last dose

• Number of subjects with abnormal laboratory parameters

  To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters

  Between screening and 7-10 days after the last dose

• Number of subjects with abnormal vital signs

  To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs

  Between screening and 7-10 days after the last dose

• Number of subjects with abnormal electrocardiogram

  To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram

  Between screening and 7-10 days after the last dose

• Number of subjects with abnormal physical examination

  To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination

  Between screening and 7-10 days after the last dose

Secondary Outcomes (4)

• The amount of GLPG1690 in plasma

  Between Day 1 predose and 48 hours after the (last) dose

• The amount of GLPG1690 in urine

  Between Day 1 predose and 24 hours after the (last) dose

• Ratio of 6-b-hydroxycortisol/cortisol in urine

  Twelve hours before dosing on Day 1 and Day 14

• Levels of biomarker in plasma

  Day 1 predose up to 48 hours post (last) dose

Study Arms (4)

GLPG1690 single dose

EXPERIMENTAL

Single oral dose of GLPG1690 suspension or solid formulation - ascending doses

Drug: GLPG1690 single ascending doses

Placebo single dose

PLACEBO COMPARATOR

Single oral dose of placebo suspension or solid formulation

Drug: Placebo single ascending doses

GLPG1690 multiple doses

EXPERIMENTAL

Multiple oral doses of GLPG1690 suspension - ascending doses

Drug: GLPG1690, multiple ascending doses, oral suspension

Placebo multiple doses

PLACEBO COMPARATOR

Multiple oral doses of placebo suspension

Drug: Placebo, multiple ascending doses, oral suspension

Interventions

GLPG1690 single ascending doses DRUG

Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg

GLPG1690 single dose

Placebo single ascending doses DRUG

Single dose, oral suspension or solid formulation matching placebo

Placebo single dose

GLPG1690, multiple ascending doses, oral suspension DRUG

Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg

GLPG1690 multiple doses

Placebo, multiple ascending doses, oral suspension DRUG

Multiple doses, daily for 14 days, oral suspension matching placebo

Placebo multiple doses

Eligibility Criteria

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

You may qualify if:

• Healthy male, age 18-50 years
• BMI between 18-30 kg/m2

You may not qualify if:

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, 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; Suspensions

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Frédéric Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2014
• First Posted: July 1, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

BE (1)