First-in-Human Single Ascending Dose of GLPG0492

February 29, 2024 updated by: Galapagos NV

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • SGS Stuivenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • elevated PSA
  • drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
single ascending doses
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast
Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution
Experimental: 3
single dose, oral solution, 50 mg
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast
Experimental: 4
single dose, capsules (fasting)
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast
Experimental: 5
single dose, capsules (fed)
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single ascending doses in healthy young and elderly subjects.
Time Frame: up to 10 days postdose
up to 10 days postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of single oral doses (solution) in young and elderly subjects.
Time Frame: up to 10 days postdose
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.
Time Frame: up to 10 days postdose
up to 10 days postdose
Determine the maximum tolerated dose in young subjects.
Time Frame: Up to 10 days postdose
Up to 10 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Investigators

  • Study Director: Florence Namour, PhD, Galapagos NV
  • Principal Investigator: Sofie Mesens, MD, SGS Stuivenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimated)

May 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GLPG0492-CL-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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