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Oral Bioavailability of GLPG0555 in Different Solid Formulations

G

Galapagos

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: GLPG0555 solid dispersion
Drug: GLPG0555 nanosuspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT01278095
GLPG0555-CL-103
2010-022457-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.

Enrollment

12 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy male
  • BMI between 18-30 kg/m², inclusive.

Exclusion criteria

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

Trial design

12 participants in 3 patient groups

GLPG0555 solid dispersion, fasting
Experimental group
Description:
50 mg as solid dispersion capsule, in fasting condition
Treatment:
Drug: GLPG0555 solid dispersion
GLPG0555 solid dispersion, fed
Experimental group
Description:
50 mg as solid dispersion capsule, after breakfast
Treatment:
Drug: GLPG0555 solid dispersion
GLPG0555 nanosuspension, fed
Experimental group
Description:
50 mg as nanosuspension, given after breakfast
Treatment:
Drug: GLPG0555 nanosuspension

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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