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

August 11, 2010 updated by: Galapagos NV

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
single ascending doses
Drug: GLPG0555
single ascending doses, oral solution
Drug: GLPG0555
multiple dose, oral solution, 7 or 14 days
Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution
Drug: placebo
multiple dose, oral solution, 7 or 14 days
Experimental: 3
multiple dose, 7 or 14 days, oral solution
Drug: GLPG0555
single ascending doses, 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
single dose, oral solution
Drug: placebo
multiple dose, oral solution, 7 or 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single and multiple dosing
Time Frame: up to 10 days postdose
up to 10 days postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of single and repeated doses, including effect of food.
Time Frame: up to 10 days postdose
up to 10 days postdose
To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration
Time Frame: up to 72 hours postdose
up to 72 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

December 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2010

Last Update Submitted That Met QC Criteria

August 11, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GLPG0555-CL-101

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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