NCT01130818

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

May 20, 2010

Last Update Submit

February 29, 2024

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokineticsBioavailability (solid vs solution, fasting vs fed)Young healthy subjectsElderly healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of single ascending doses in healthy young and elderly subjects.

    up to 10 days postdose

Secondary Outcomes (3)

  • Pharmacokinetics of single oral doses (solution) in young and elderly subjects.

    up to 10 days postdose

  • Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food.

    up to 10 days postdose

  • Determine the maximum tolerated dose in young subjects.

    Up to 10 days postdose

Study Arms (5)

1

EXPERIMENTAL

single ascending doses

Drug: GLPG0492

2

PLACEBO COMPARATOR

single dose placebo

Drug: placebo

3

EXPERIMENTAL

single dose, oral solution, 50 mg

Drug: GLPG0492

4

EXPERIMENTAL

single dose, capsules (fasting)

Drug: GLPG0492

5

EXPERIMENTAL

single dose, capsules (fed)

Drug: GLPG0492

Interventions

GLPG0492DRUG

single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)

13
placeboDRUG

single dose, oral solution

2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)
  • BMI between 18-30 kg/m², inclusive
  • non-smoker

You may not qualify if:

  • elevated PSA
  • drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Stuivenberg

Antwerp, Belgium

Location

MeSH Terms

Interventions

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

Study Officials

  • Florence Namour, PhD

    Galapagos NV

    STUDY DIRECTOR

  • Sofie Mesens, 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
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 26, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

BE(1)