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

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ClinicalTrials.gov Identifier: NCT01208753
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:
Galapagos NV

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: GLPG0555 Drug: GLPG0555 aqueous Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
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




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

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics