Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects

Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects

The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.

Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG0634 50 mg; Drug: GLPG0634 100 mg; Drug: GLPG0634 200 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Hammersmith Medicines Research (HMR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
• Subjects must have a body mass index between 18-28 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 profile

Exclusion Criteria:

• A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
• Concurrent participation or participation within 3 months prior to the initial study drug administration in a drug/device or biologic investigational research study
• A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
• Subject expresses current desire to have (more) children
• Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLPG0634 in Japanese subjects; Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days	Drug: GLPG0634 50 mg; 2 tablets of 25 mg GLPG0634 once daily for 10 days; Other Names: 50 mg GLPG0634 as tablets; Drug: GLPG0634 100 mg; 1 tablet of 100 mg GLPG0634 once daily for 10 days; Other Names: 100 mg GLPG0634 as tablets; Drug: GLPG0634 200 mg; 2 tablets of 100 mg GLPG0634 once daily for 10 days; Other Names: 200 mg GLPG0634 as tablets
Placebo Comparator: Placebo in Japanese healthy subjects; Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days	Drug: Placebo; 1 or 2 matching placebo tablets once daily for 10 days; Other Names: Placebo as matching tablets
Experimental: GLPG0634 in Caucasian subjects; In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days	Drug: GLPG0634 200 mg; 2 tablets of 100 mg GLPG0634 once daily for 10 days; Other Names: 200 mg GLPG0634 as tablets
Placebo Comparator: Placebo in Caucasian healthy subjects; In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days	Drug: Placebo; 1 or 2 matching placebo tablets once daily for 10 days; Other Names: Placebo as matching tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects with adverse events	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs)	From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters	From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal vital signs	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs	From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal electrocardiogram	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram	From screening up to 10 days after last dose (Day 20)
The number of subjects with abnormal physical examination	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination	From screening up to 10 days after last dose (Day 20)
The amount of GLPG0634 and metabolite in plasma and urine	To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested Safety Issue?: No	Between Day 1 before dosing and Day 13 (72 hours after last dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood	To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested	Between Day 1 before dosing and Day 11 (24 hours after last dose)

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Pille Harrison, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 14, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: GLPG0634-CL-110; 2013-004408-21 (EudraCT Number)