NCT02162355 - Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

36

Conditions

Healthy

Interventions

GLPG0634 50 mgDRUG

2 tablets of 25 mg GLPG0634 once daily for 10 days

GLPG0634 100 mgDRUG

1 tablet of 100 mg GLPG0634 once daily for 10 days

GLPG0634 200 mgDRUG

2 tablets of 100 mg GLPG0634 once daily for 10 days

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Outcomes

Primary Outcomes

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)