GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: GLPG0778

Study type: Interventional

Funder types: Industry

Identifiers

NCT01336244

GLPG0778-CL-102

2011-000892-16 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

Enrollment: 45 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male, age 18-50 years
• body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion criteria

• significantly abnormal platelet function or coagulopathy
• smoking
• drug or alcohol abuse
• hypersensitivity to any of the test substances

Trial design

45 participants in 2 patient groups, including a placebo group

GLPG0778 ascending doses

Experimental group

Description:

Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.

Treatment:

Drug: GLPG0778

Placebo

Placebo Comparator group

Description:

Twice daily for 13 days, matching the scheme of the multiple ascending dose.

Treatment:

Drug: placebo