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

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT00928343
First received: June 23, 2009
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Healthy
Drug: GLPG0187
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of single subcutaneous and oral dosing [ Time Frame: up to day 10 postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of single subcutaneous and oral doses [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • Exploratory evaluation of S-CTX [ Time Frame: up to 24 hrs postdose ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT00928343     History of Changes
Other Study ID Numbers: GLPG0187-CL-101
Study First Received: June 23, 2009
Last Updated: January 14, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on August 28, 2014