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

NCT02162355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-09-16

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

GLPG0634 50 mg

2 tablets of 25 mg GLPG0634 once daily for 10 days

DRUG

GLPG0634 100 mg

1 tablet of 100 mg GLPG0634 once daily for 10 days

DRUG

GLPG0634 200 mg

2 tablets of 100 mg GLPG0634 once daily for 10 days

DRUG

Placebo

1 or 2 matching placebo tablets once daily for 10 days

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Pille Harrison, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02162355 on ClinicalTrials.gov