Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01208753
First received: September 23, 2010
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.


Condition Intervention Phase
Healthy
Drug: GLPG0555
Drug: GLPG0555 aqueous
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, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of multiple dosing [ Time Frame: Daily during treatment, up to 10 days postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of repeated doses [ Time Frame: 24 hours postdose ] [ Designated as safety issue: No ]
  • Pharmacodynamics (PD) of GLPG0555 after repeated oral administration [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days [ Time Frame: up to 24 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aqueous formulations for formulation selection
50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation
Drug: GLPG0555
two different aqueous formulations
Experimental: GLPG0555 ascending doses
multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily)
Drug: GLPG0555 aqueous
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
Placebo Comparator: 3
once or twice daily for 13 days, matching the scheme of the multiple ascending dose.
Drug: placebo
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

  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: NCT01208753

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: NCT01208753     History of Changes
Other Study ID Numbers: GLPG0555-CL-102, 2010-018570-20
Study First Received: September 23, 2010
Last Updated: March 22, 2011
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 April 17, 2014