First-in-Human Single and Multiple Dose of GLPG1837

Healthy Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG1837 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325037
• Other study ID #: GLPG1837-CL-101
• Secondary ID: 2014-003853-32
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2014
• Last updated: September 7, 2015
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1837 single ascending doses
Single dose, oral suspension
• Placebo single dose
Single dose, oral suspension matching placebo
• GLPG1837 multiple ascending doses
Multiple doses, daily for 14 days, oral suspension
• Placebo multiple doses
Multiple doses, daily for 14 days, oral suspension, matching placebo

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events	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	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal laboratory parameters	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	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal vital signs	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	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal electrocardiogram	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	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal physical examination	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	Between screening and 7-10 days after the last dose	Yes
Secondary	The amount of GLPG1837 and its metabolite in plasma	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	Between Day 1 predose and 48 hours after the (last) dose	No
Secondary	The amount of GLPG1837 and its metabolite in urine	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	Between Day 1 predose and 24 hours after the (last) dose	No
Secondary	Ratio of 6-b-hydroxycortisol/cortisol in urine	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	Twelve hours before dosing on Day 1 and Day 14	No