NCT00989703

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

October 2, 2009

Last Update Submit

February 17, 2012

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of oral multiple ascending doses

    up to 10 days postdose

Secondary Outcomes (3)

  • Pharmacokinetics of multiple oral doses

    up to 10 days postdose

  • To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).

    up to 10 days postdose

  • To explore biomarkers of GLPG0259 activity after multiple oral administrations.

    up to 24 hours postdose

Study Arms (2)

1

EXPERIMENTAL

GLPG0259 25/50/75 mg/day for 14 days

Drug: GLPG0259Drug: Methotrexate

2

PLACEBO COMPARATOR

placebo for 14 days

Drug: placeboDrug: Methotrexate

Interventions

placeboDRUG

oral solution, daily for 14 days

2
GLPG0259DRUG

oral solution

1
MethotrexateDRUG

7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14

Also known as: Ledertrexate®
12

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

Methotrexate

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Johan Beetens, PharmD, PhD

    Galapagos NV

    STUDY DIRECTOR

  • Lien Gheyle, 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

BE(1)