First-in-Human Single and Multiple Dose of GLPG1972

Healthy Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1972 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612246
• Other study ID #: GLPG1972-CL-101
• Secondary ID: 2015-004156-21
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2015
• Last updated: July 28, 2016
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2016
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

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

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:
• GLPG1972 single ascending doses
single dose, oral solution
• Placebo single dose
single dose, oral solution, matching placebo
• GLPG1972 multiple ascending doses
multiple doses, daily for 14 days, oral solution
• Placebo multiple doses
multiple doses, daily for 14 days, oral solution

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	Change versus placebo in number of subjects with adverse events	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	Between screening and 7-10 days after the last dose	Yes
Primary	Change versus placebo in number of subjects with abnormal laboratory parameters	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	Between screening and 7-10 days after the last dose	Yes
Primary	Change versus placebo in number of subjects with abnormal vital signs	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	Between screening and 7-10 days after the last dose	Yes
Primary	Change versus placebo in number of subjects with abnormal electrocardiogram	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	Between screening and 7-10 days after the last dose	Yes
Primary	Change versus placebo in number of subjects with abnormal physical examination	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	Between screening and 7-10 days after the last dose	Yes
Secondary	The amount of GLPG1972 in plasma	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	Between Day 1 predose and 48 hours after the (last) dose	No
Secondary	The amount of GLPG1972 in urine	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	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 interaction after repeated oral dosing with GLPG1972 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine	Twelve hours before dosing on Day 1 and Day 14	No
Secondary	Levels of GLPG1972 biomarker in blood	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	Between Day 1 predose and 48 hours after the last dose	No