NCT01496937

Brief Summary

The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects. Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

1 month

First QC Date

December 16, 2011

Last Update Submit

April 18, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The amount of GLPG0974 in plasma over time after a single oral dose

    To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects

Secondary Outcomes (2)

  • Safety and tolerability

  • Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974

Study Arms (2)

GLPG0974 oral solution

EXPERIMENTAL

GLPG0974 oral solution

Drug: GLPG0974

Placebo oral solution

PLACEBO COMPARATOR

Placebo oral solution

Drug: GLPG0974

Interventions

GLPG0974DRUG
GLPG0974 oral solution

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

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, Belgium

Location

MeSH Terms

Interventions

4-(((R)-1-(benzo(b)thiophene-3-carbonyl)-2-methyl-azetidine-2-carbonyl)-(3-chloro-benzyl)-amino)-butyric acid

Study Officials

  • Frédéric Vanhoutte, MD

    Galapagos NV

    STUDY DIRECTOR

  • Wouter Haazen, 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

December 16, 2011

First Posted

December 21, 2011

Study Start

December 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

BE(1)