Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0555 aqueous; Drug: GLPG0555; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208753

2010-018570-20 (EudraCT Number)

GLPG0555-CL-102

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

Enrollment: 24 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

24 participants in 3 patient groups, including a placebo group

Aqueous formulations for formulation selection

Experimental group

Description:

50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation

Treatment:

Drug: GLPG0555

GLPG0555 ascending doses

Experimental group

Description:

multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily)

Treatment:

Drug: GLPG0555 aqueous

3

Placebo Comparator group

Description:

once or twice daily for 13 days, matching the scheme of the multiple ascending dose.

Treatment:

Drug: placebo