NCT01397370

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple oral administrations.

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 Jul 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

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

July 18, 2011

Last Update Submit

February 17, 2012

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of GLPG0492 in terms of adverse events, vital signs, ECG and abnormal lab tests in comparison with placebo

    Occurrence of adverse events, vital signs, ECG and abnormal lab tests as a measure of safety and tolerability

    Up to 2 weeks after last treatment

Secondary Outcomes (2)

  • To determine the pharmacokinetic profile and metabolism after single and multiple doses of GLPG0492

    Up to 2h hours after last treatment

  • To assess whether GLPG0492 induces CYP450, a pharmacodynamic marker by measuring the ratio of β-OH-cortisol /cortisol in urine

    Up to 24 hours after last treatment

Study Arms (2)

GLPG0492 oral solution

EXPERIMENTAL

Multiple ascending doses once daily for 14 days, starting from 5 mg/day

Drug: GLPG0492

Placebo oral solution

PLACEBO COMPARATOR

Once daily dosing for 14 days

Drug: Placebo

Interventions

GLPG0492DRUG

Oral solution

GLPG0492 oral solution
PlaceboDRUG

Oral solution

Placebo 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
  • body mass index (BMI) between 18-29.9 kg/m², inclusive.
  • normal values of testosterone (2.49-8.36 ng/mL) and LH (1.7-8.6 U/L)

You may not qualify if:

  • smoking
  • drug or alcohol abuse
  • hypersensitivity to any of the ingredients of the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel Early Phase Clinical Unit

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

4-(4-(hydroxymethyl)-3-methyl-2,5-dioxo-4-phenylimidazolidin-1-yl)-2-(trifluoromethyl)benzonitrile

Study Officials

  • Frédéric Vanhoutte, MD

    Galapagos NV

    STUDY DIRECTOR

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

July 18, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

DE(1)