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

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01023321
First received: December 1, 2009
Last updated: August 11, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: GLPG0555
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 and Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of single and multiple dosing [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of single and repeated doses, including effect of food. [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration [ Time Frame: up to 72 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023321

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

No publications provided

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01023321     History of Changes
Other Study ID Numbers: GLPG0555-CL-101
Study First Received: December 1, 2009
Last Updated: August 11, 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 May 19, 2013