NCT00928343

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Typical duration 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

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

June 23, 2009

Last Update Submit

January 14, 2010

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of single subcutaneous and oral dosing

    up to day 10 postdose

Secondary Outcomes (2)

  • Pharmacokinetics of single subcutaneous and oral doses

    up to 10 days postdose

  • Exploratory evaluation of S-CTX

    up to 24 hrs postdose

Study Arms (2)

GLPG0187

EXPERIMENTAL

Single dose

Drug: GLPG0187

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GLPG0187DRUG

Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)

GLPG0187
PlaceboDRUG

Matching subcutaneous or oral placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • healthy male, age 18-50 years
  • 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, Belgium

Location

MeSH Terms

Interventions

GLPG0187

Study Officials

  • Giocondo Lorenzon, PhD

    Galapagos NV

    STUDY DIRECTOR

  • Eva Vets, MD

    SGS Stuivenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

BE(1)