First-in-Human Single and Multiple Dose of GLPG1837

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo single dose; Drug: GLPG1837 single ascending doses; Drug: GLPG1837 multiple ascending doses; Drug: Placebo multiple doses

• Registration Number: NCT02325037
• 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 GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy 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 GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.

The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-24
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Males or females of non-child bearing potential between 18-50 years of age (included)
• Subjects must have a body mass index between 18-30 kg/m² (included)
• 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 findings

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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 or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration
• 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 should be used
• Pregnant or lactating women or women of childbearing potential

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo single dose	Placebo single dose	Single oral dose of placebo suspension
GLPG1837 single dose	GLPG1837 single ascending doses	Single oral dose of GLPG1837 suspension - ascending doses
GLPG1837 muliple doses	GLPG1837 multiple ascending doses	Multiple oral doses of GLPG1837 suspension - ascending doses
Placebo multiple doses	Placebo multiple doses	Multiple oral doses of placebo suspension

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Number of subjects with abnormal laboratory parameters	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
Number of subjects with abnormal vital signs	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Number of subjects with abnormal electrocardiogram	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
Number of subjects with abnormal physical examination	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination

Secondary Outcome Measures

Name	Time	Method
Ratio of 6-b-hydroxycortisol/cortisol in urine	Twelve hours before dosing on Day 1 and Day 14	To assess the potential of CYP3A4 induction after repeated oral dosing with GLPG1837 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
The amount of GLPG1837 and its metabolite in plasma	Between Day 1 predose and 48 hours after the (last) dose	To characterize the amount of GLPG1837 and its metabolite in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed
The amount of GLPG1837 and its metabolite in urine	Between Day 1 predose and 24 hours after the (last) dose	To characterize the amount of GLPG1837 and its metabolite in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed

Trial Locations

Locations (1)

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