NCT01278095

Brief Summary

The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

January 14, 2011

Last Update Submit

March 23, 2011

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of solid formulation

    72 hrs

Secondary Outcomes (1)

  • Safety and tolerability of single doses of GLPG0555

    up to 10 days postdose

Study Arms (3)

GLPG0555 solid dispersion, fasting

EXPERIMENTAL

50 mg as solid dispersion capsule, in fasting condition

Drug: GLPG0555 solid dispersion

GLPG0555 solid dispersion, fed

EXPERIMENTAL

50 mg as solid dispersion capsule, after breakfast

Drug: GLPG0555 solid dispersion

GLPG0555 nanosuspension, fed

EXPERIMENTAL

50 mg as nanosuspension, given after breakfast

Drug: GLPG0555 nanosuspension

Interventions

GLPG0555 solid dispersionDRUG

solid dispersion capsules, 50 mg, single dose

GLPG0555 solid dispersion, fastingGLPG0555 solid dispersion, fed
GLPG0555 nanosuspensionDRUG

Nanosuspension, 50 mg, single dose

GLPG0555 nanosuspension, fed

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male
  • BMI between 18-30 kg/m², inclusive.

You may not qualify if:

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Stuivenberg

Antwerp, 2060, Belgium

Location

Study Officials

  • Gerben van 't Klooster, PhD

    Galapagos NV

    STUDY DIRECTOR

  • Jos Leempoels, MD

    SGS Stuivenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

BE(1)