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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0634 50 mg; Drug: Placebo; Drug: GLPG0634 100 mg; Drug: GLPG0634 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02162355

2013-004408-21 (EudraCT Number)

GLPG0634-CL-110

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

36 participants in 4 patient groups, including a placebo group

GLPG0634 in Japanese subjects

Experimental group

Description:

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

Treatment:

Drug: GLPG0634 200 mg

Drug: GLPG0634 100 mg

Drug: GLPG0634 50 mg

Placebo in Japanese healthy subjects

Placebo Comparator group

Description:

Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days

Treatment:

Drug: Placebo

GLPG0634 in Caucasian subjects

Experimental group

Description:

In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days

Treatment:

Drug: GLPG0634 200 mg

Placebo in Caucasian healthy subjects

Placebo Comparator group

Description:

In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days

Treatment:

Drug: Placebo