NCT01336244

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

April 13, 2011

Last Update Submit

October 17, 2011

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Occurrence of adverse events

    At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.

    Daily during treatment, up to 10 days postdose

  • Evaluation of hematological, biochemical and cardiovascular parameters.

    On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.

    until 10 days postdose.

Secondary Outcomes (2)

  • Pharmacokinetics of repeated doses

    24 hours postdose

  • Pharmacodynamics (PD) of GLPG0778

    up to 10 days postdose

Study Arms (2)

GLPG0778 ascending doses

EXPERIMENTAL

Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.

Drug: GLPG0778

Placebo

PLACEBO COMPARATOR

Twice daily for 13 days, matching the scheme of the multiple ascending dose.

Drug: placebo

Interventions

GLPG0778DRUG

capsules containing 50 or 100 mg of GLPG0778

GLPG0778 ascending doses
placeboDRUG

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Placebo

Eligibility Criteria

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

You may qualify if:

  • healthy male, age 18-50 years
  • body mass index (BMI) between 18-30 kg/m², inclusive.

You may not qualify if:

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse
  • hypersensitivity to any of the test substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Stuivenberg

Antwerp, Belgium

Location

Study Officials

  • Gerben van 't Klooster, 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

April 13, 2011

First Posted

April 15, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

BE(1)