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Completed

NCT Number: NCT01130818

First-in-Human Single Ascending Dose of GLPG0492

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Stuivenberg

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLPG0492

Drug

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

Placebo

Drug

single dose, oral solution

Primary outcomes

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

    Time frame: up to 10 days postdose

Secondary outcomes

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

    Time frame: up to 10 days postdose

  2. 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

  3. Determine the maximum tolerated dose in young subjects.

    Time frame: Up to 10 days postdose

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 26, 2010
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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