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

March 22, 2011 updated by: Galapagos NV

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • SGS Stuivenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of multiple dosing
Time Frame: Daily during treatment, up to 10 days postdose
Daily during treatment, up to 10 days postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of repeated doses
Time Frame: 24 hours postdose
24 hours postdose
Pharmacodynamics (PD) of GLPG0555 after repeated oral administration
Time Frame: up to 10 days postdose
up to 10 days postdose
The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days
Time Frame: up to 24 hours postdose
up to 24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (ESTIMATE)

September 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GLPG0555-CL-102
  • 2010-018570-20 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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