First-in-Human Single Ascending and Multiple Dose of GLPG0259

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00905138
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : February 20, 2012
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 GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 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: GLPG0259 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: 1
single ascending doses
Drug: GLPG0259
single ascending doses, oral solution
Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution
Experimental: 3
multiple dose, 5 days, oral solution
Drug: GLPG0259
multiple dose, oral solution, 5 days
Placebo Comparator: 4
multiple dose, 5 days, oral solution
Drug: placebo
oral solution, 5 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 [ Time Frame: up to 10 days postdose ]
  2. Exploratory evaluation of TNF-alpha and IL6 in whole blood [ Time Frame: up to 12 hours postdose ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00905138

SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Study Director: Johan Beetens, PharmD, PhD Galapagos NV
Principal Investigator: Eva Vets, MD SGS Stuivenberg

Responsible Party: Senior Vice President Development, Galapagos NV Identifier: NCT00905138     History of Changes
Other Study ID Numbers: GLPG0259-CL-101
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by Galapagos NV:

Additional relevant MeSH terms:
Pharmaceutical Solutions