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

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ClinicalTrials.gov Identifier: NCT00928343
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : January 15, 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) 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.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG0187 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 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 Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.
Study Start Date : June 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: GLPG0187
Single dose
Drug: GLPG0187
Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
Placebo Comparator: Placebo Drug: Placebo
Matching subcutaneous or oral placebo



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

Secondary Outcome Measures :
  1. Pharmacokinetics of single subcutaneous and oral doses [ Time Frame: up to 10 days postdose ]
  2. Exploratory evaluation of S-CTX [ Time Frame: up to 24 hrs 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): NCT00928343


Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Giocondo Lorenzon, PhD Galapagos NV
Principal Investigator: Eva Vets, MD SGS Stuivenberg

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT00928343     History of Changes
Other Study ID Numbers: GLPG0187-CL-101
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics