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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0634 50 mg; Drug: Placebo; Drug: GLPG0634 100 mg; Drug: GLPG0634 200 mg

• Registration Number: NCT02162355
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-14
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG0634 in Japanese subjects	GLPG0634 50 mg	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
Placebo in Caucasian healthy subjects	Placebo	In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days
Placebo in Japanese healthy subjects	Placebo	Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days
GLPG0634 in Japanese subjects	GLPG0634 100 mg	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
GLPG0634 in Japanese subjects	GLPG0634 200 mg	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
GLPG0634 in Caucasian subjects	GLPG0634 200 mg	In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days

Primary Outcome Measures

Name	Time	Method
The number of subjects with abnormal electrocardiogram	From screening up to 10 days after last dose (Day 20)	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
The amount of GLPG0634 and metabolite in plasma and urine	Between Day 1 before dosing and Day 13 (72 hours after last dose)	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
The number of subjects with abnormal laboratory parameters	From screening up to 10 days after last dose (Day 20)	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
The number of subjects with adverse events	From screening up to 10 days after last dose (Day 20)	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)
The number of subjects with abnormal vital signs	From screening up to 10 days after last dose (Day 20)	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
The number of subjects with abnormal physical examination	From screening up to 10 days after last dose (Day 20)	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

Secondary Outcome Measures

Name	Time	Method
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood	Between Day 1 before dosing and Day 11 (24 hours after last dose)	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

Trial Locations

Locations (1)

Hammersmith Medicines Research (HMR); 🇬🇧 London, United Kingdom