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First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928343
First Posted: June 25, 2009
Last Update Posted: January 15, 2010
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.
Information provided by:
Galapagos NV
June 23, 2009
June 25, 2009
January 15, 2010
June 2009
November 2009   (Final data collection date for primary outcome measure)
Safety and tolerability of single subcutaneous and oral dosing [ Time Frame: up to day 10 postdose ]
Same as current
Complete list of historical versions of study NCT00928343 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of single subcutaneous and oral doses [ Time Frame: up to 10 days postdose ]
  • Exploratory evaluation of S-CTX [ Time Frame: up to 24 hrs postdose ]
Same as current
Not Provided
Not Provided
 
First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • Drug: GLPG0187
    Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
  • Drug: Placebo
    Matching subcutaneous or oral placebo
  • Experimental: GLPG0187
    Single dose
    Intervention: Drug: GLPG0187
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00928343
GLPG0187-CL-101
No
Not Provided
Not Provided
Senior Vice President Development, Galapagos NV
Galapagos NV
Not Provided
Study Director: Giocondo Lorenzon, PhD Galapagos NV
Principal Investigator: Eva Vets, MD SGS Stuivenberg
Galapagos NV
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP