First-in-Human Single and Multiple Dose of GLPG1972

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG1972 single ascending doses; Drug: Placebo single dose; Drug: GLPG1972 multiple ascending doses; Drug: Placebo multiple doses

• Registration Number: NCT02612246
• 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 GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 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 GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well.

During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-23
• Status Verified: 2016-03
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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

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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 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 should be used

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG1972 single dose	GLPG1972 single ascending doses	Single oral dose of GLPG1972 solution - ascending doses
Placebo single dose	Placebo single dose	Single oral dose of placebo solution
GLPG1972 multiple doses	GLPG1972 multiple ascending doses	Multiple oral doses of GLPG1972 solution - ascending doses
Placebo multiple doses	Placebo multiple doses	Multiple oral doses of placebo solution

Primary Outcome Measures

Name	Time	Method
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 GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
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 GLPG1972 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 adverse events	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1972 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 GLPG1972 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 vital signs	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG1972 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs

Secondary Outcome Measures

Name	Time	Method
Levels of GLPG1972 biomarker in blood	Between Day 1 predose and 48 hours after the last dose	To assess the pharmacodynamics (PD) of GLPG1972 by means of reduction of levels of biomarker in blood by GLPG1972 compared to placebo after repeated oral dosing
The amount of GLPG1972 in urine	Between Day 1 predose and 24 hours after the (last) dose	To characterize the amount of GLPG1972 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed
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 GLPG1972 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
The amount of GLPG1972 in plasma	Between Day 1 predose and 48 hours after the (last) dose	To characterize the amount of GLPG1972 in plasma 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