First-in-Human Single and Multiple Dose of GLPG2222

Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.

The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG2222 single dose; Drug: Placebo single dose; Drug: GLPG2222 multiple doses; Drug: Placebo multiple doses

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • SGS LSS Clinical Pharmacology Unit Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males between 18-50 years of age
• Subjects must have a body mass index between 18-30 kg/m²
• Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
• Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)

Exclusion Criteria:

• A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
• Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study
• A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
• Current sexually active (and/or child wish) male; a contraception method must be used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG2222 single dose; Single dose of GLPG2222 oral suspension	Drug: GLPG2222 single dose; single ascending doses, oral suspension
Placebo Comparator: Placebo single dose; Single dose of placebo oral suspension	Drug: Placebo single dose; single doses, oral suspension, matching placebo
Experimental: GLPG2222 multiple doses; Multiple doses of GLPG2222 oral suspension	Drug: GLPG2222 multiple doses; multiple ascending doses, daily for 14 days, oral suspension
Placebo Comparator: Placebo multiple doses; Multiple doses of placebo oral suspension	Drug: Placebo multiple doses; multiple doses, daily for 14 days, oral suspension, matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change versus placebo in number of subjects with adverse events	To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events	Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters	Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal vital signs	To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs	Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal electrocardiogram	To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram	Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal physical examination	To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination	Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal pulmonary function	To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry	Between screening and 4 days after the last dose (Part 1 only)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of GLPG2222 in plasma	To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects	Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG2222 in urine	To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects	Between Day 1 predose and 24 hours after the (last) dose
Ratio of 6-b-hydroxycortisol/cortisol in urine	To assess the potential of CYP3A4 interaction after repeated oral dosing with GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine	Twelve hours before dosing on Day 1 and Day 14

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Kirsteen Donaldson, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GLPG2222-CL-101; 2015-004466-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No