NCT01419990

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo. During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 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

August 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

August 17, 2011

Last Update Submit

August 14, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

    From screening up to 10 days after the last dose

Secondary Outcomes (1)

  • Pharmacokinetics (PK) and pharmacodynamics (PD)

    From first dose up to 10 days after the last dose

Study Arms (2)

GLPG0634 capsules

EXPERIMENTAL
Drug: GLPG0634

Placebo capsules

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GLPG0634DRUG

GLPG0634 300 mg oral capsules, qd, 10 days

GLPG0634 capsules
PlaceboDRUG

Placebo oral capsules, qd, 10 days

Placebo capsules

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male, age 40-60 years
  • BMI between 18-30 kg/m2

You may not qualify if:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Stuivenberg

Antwerp, Antwerp, 2060, Belgium

Location

Related Publications (1)

  • Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.

    PMID: 25681059DERIVED

MeSH Terms

Interventions

GLPG0634

Study Officials

  • Frédéric Vanhoutte, MD

    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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 19, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

BE(1)