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Completed

NCT Number: NCT01278108

First-in-Human Single Ascending and Multiple Dose of GLPG0778

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Stuivenberg

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy male
  • body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion criteria

  • any condition that might interfere with the procedures or tests in the study
  • smoking
  • drug or alcohol abuse

Treatment and study plan

GLPG0778

Drug

single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)

Placebo

Drug

single dose, oral solution or capsule (matching corresponding study medication)

Primary outcomes

  1. Safety and tolerability of single and multiple dosing

    Time frame: up to 10 days postdose

    Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.

Secondary outcomes

  1. Pharmacokinetics of single and repeated doses, including effect of food.

    Time frame: up to 10 days postdose

    Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Double-blind, Placebo-controlled, Dose-ranging Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Oral Doses, and Multiple Oral Doses of GLPG0778 in Healthy Subjects.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2011
Registry last updated
Oct 18, 2011

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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