First-in-Human Single Ascending and Multiple Dose of GLPG0778

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0778; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278108

2010-023199-16 (EudraCT Number)

GLPG0778-CL-101

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male
• body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion criteria

• any condition that might interfere with the procedures or tests in the study
• smoking
• drug or alcohol abuse

Trial design

40 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

single ascending doses

Treatment:

Drug: GLPG0778

Drug: GLPG0778

2

Placebo Comparator group

Description:

single dose placebo

Treatment:

Drug: placebo

Drug: placebo

3

Experimental group

Description:

multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).

Treatment:

Drug: GLPG0778

Drug: GLPG0778

4

Placebo Comparator group

Description:

multiple dose, capsules, 7 days; scheme to match that of Study Arm 3.

Treatment:

Drug: placebo

Drug: placebo