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

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01208753
First received: September 23, 2010
Last updated: March 22, 2011
Last verified: March 2011
  Purpose
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.

Condition Intervention Phase
Healthy Drug: GLPG0555 Drug: GLPG0555 aqueous Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of multiple dosing [ Time Frame: Daily during treatment, up to 10 days postdose ]

Secondary Outcome Measures:
  • Pharmacokinetics of repeated doses [ Time Frame: 24 hours postdose ]
  • Pharmacodynamics (PD) of GLPG0555 after repeated oral administration [ Time Frame: up to 10 days postdose ]
  • The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days [ Time Frame: up to 24 hours postdose ]

Enrollment: 24
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aqueous formulations for formulation selection
50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation
Drug: GLPG0555
two different aqueous formulations
Experimental: GLPG0555 ascending doses
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)
Drug: GLPG0555 aqueous
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
Placebo Comparator: 3
once or twice daily for 13 days, matching the scheme of the multiple ascending dose.
Drug: placebo
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208753

Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Gerben van 't Klooster, PhD Galapagos NV
Principal Investigator: Wouter Haazen, MD SGS Stuivenberg
  More Information

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01208753     History of Changes
Other Study ID Numbers: GLPG0555-CL-102
2010-018570-20 ( EudraCT Number )
Study First Received: September 23, 2010
Last Updated: March 22, 2011

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on June 23, 2017