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Completed

NCT Number: NCT01336244

GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

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

Exclusion criteria

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse
  • hypersensitivity to any of the test substances

Treatment and study plan

GLPG0778

Drug

capsules containing 50 or 100 mg of GLPG0778

Placebo

Drug

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Primary outcomes

  1. Occurrence of adverse events

    Time frame: Daily during treatment, up to 10 days postdose

    At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.

  2. Evaluation of hematological, biochemical and cardiovascular parameters.

    Time frame: until 10 days postdose.

    On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.

Secondary outcomes

  1. Pharmacokinetics of repeated doses

    Time frame: 24 hours 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).

  2. Pharmacodynamics (PD) of GLPG0778

    Time frame: up to 10 days postdose

    To explore biomarkers of GLPG0778 activity after repeated oral administrations.

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, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 15, 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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