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First-in-Human Single Ascending and Multiple Dose of GLPG0555

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ClinicalTrials.gov Identifier: NCT01023321
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : August 12, 2010
Sponsor:
Information provided by:
Galapagos NV

Brief Summary:

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG0555 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 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 (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0555 in Healthy Subjects.
Study Start Date : December 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: 1
single ascending doses
Drug: GLPG0555
single ascending doses, oral solution

Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution

Experimental: 3
multiple dose, 7 or 14 days, oral solution
Drug: GLPG0555
multiple dose, oral solution, 7 or 14 days

Placebo Comparator: 4
multiple dose, 7 or 14 days, oral solution
Drug: placebo
multiple dose, oral solution, 7 or 14 days




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

Secondary Outcome Measures :
  1. Pharmacokinetics of single and repeated doses, including effect of food. [ Time Frame: up to 10 days postdose ]
  2. To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration [ Time Frame: up to 72 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): NCT01023321


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

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Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01023321     History of Changes
Other Study ID Numbers: GLPG0555-CL-101
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

Additional relevant MeSH terms:
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Pharmaceutical Solutions