First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: GLPG0187

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928343

GLPG0187-CL-101

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male, age 18-50 years
• BMI between 18-30 kg/m², inclusive

Exclusion criteria

• significantly abnormal platelet function or coagulopathy
• smoking
• drug or alcohol abuse

Trial design

18 participants in 2 patient groups, including a placebo group

GLPG0187

Experimental group

Description:

Single dose

Treatment:

Drug: GLPG0187

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo