First-in-Human Single and Multiple Dose of GLPG2222

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG2222 multiple doses; Drug: Placebo multiple doses; Drug: GLPG2222 single dose; Drug: Placebo single dose

• Registration Number: NCT02662452
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG2222 multiple doses	GLPG2222 multiple doses	Multiple doses of GLPG2222 oral suspension
Placebo multiple doses	Placebo multiple doses	Multiple doses of placebo oral suspension
GLPG2222 single dose	GLPG2222 single dose	Single dose of GLPG2222 oral suspension
Placebo single dose	Placebo single dose	Single dose of placebo oral suspension

Primary Outcome Measures

Name	Time	Method
Change versus placebo in number of subjects with adverse events	Between screening and 7-10 days after the last dose	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
Change versus placebo in number of subjects with abnormal laboratory parameters	Between screening and 7-10 days after the last dose	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
Change versus placebo in number of subjects with abnormal physical examination	Between screening and 7-10 days after the last dose	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
Change versus placebo in number of subjects with abnormal pulmonary function	Between screening and 4 days after the last dose (Part 1 only)	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
Change versus placebo in number of subjects with abnormal vital signs	Between screening and 7-10 days after the last dose	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
Change versus placebo in number of subjects with abnormal electrocardiogram	Between screening and 7-10 days after the last dose	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

Secondary Outcome Measures

Name	Time	Method
The amount of GLPG2222 in plasma	Between Day 1 predose and 48 hours after the (last) dose	To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
The amount of GLPG2222 in urine	Between Day 1 predose and 24 hours after the (last) dose	To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Ratio of 6-b-hydroxycortisol/cortisol in urine	Twelve hours before dosing on Day 1 and Day 14	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

Trial Locations

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium