First-in-Human Single and Multiple Dose of GLPG1690

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG1690 single ascending doses; Drug: GLPG1690, multiple ascending doses, oral suspension; Drug: Placebo, multiple ascending doses, oral suspension; Drug: Placebo single ascending doses

• Registration Number: NCT02179502
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-28
• Study First Submitted QC: 2014-06-28
• Study First Posted: 2014-07-01
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-20
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

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

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG1690 single dose	GLPG1690 single ascending doses	Single oral dose of GLPG1690 suspension or solid formulation - ascending doses
GLPG1690 multiple doses	GLPG1690, multiple ascending doses, oral suspension	Multiple oral doses of GLPG1690 suspension - ascending doses
Placebo multiple doses	Placebo, multiple ascending doses, oral suspension	Multiple oral doses of placebo suspension
Placebo single dose	Placebo single ascending doses	Single oral dose of placebo suspension or solid formulation

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 GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events
Number of subjects with abnormal vital signs	Between screening and 7-10 days after the last dose	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
Number of subjects with abnormal electrocardiogram	Between screening and 7-10 days after the last dose	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
Number of subjects with abnormal physical examination	Between screening and 7-10 days after the last dose	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
Number of subjects with abnormal laboratory parameters	Between screening and 7-10 days after the last dose	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

Secondary Outcome Measures

Name	Time	Method
The amount of GLPG1690 in plasma	Between Day 1 predose and 48 hours after the (last) dose	To characterize the amount of GLPG1690 in plasma over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation
Levels of biomarker in plasma	Day 1 predose up to 48 hours post (last) dose	To characterize the pharmacodynamics (PD) of GLPG1690 by means of reduction of levels of biomarker by GLPG1690 compared to placebo in plasma after single and multiple oral dose in healthy subjects
The amount of GLPG1690 in urine	Between Day 1 predose and 24 hours after the (last) dose	To characterize the amount of GLPG1690 in urine over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation
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 dosing with GLPG1690 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine

Trial Locations

Locations (1)

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