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OpenTrials
Completed

NCT Number: NCT00928343

First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and 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, 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
  • BMI between 18-30 kg/m², inclusive

Exclusion criteria

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse

Treatment and study plan

GLPG0187

Drug

Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)

Placebo

Drug

Matching subcutaneous or oral placebo

Primary outcomes

  1. Safety and tolerability of single subcutaneous and oral dosing

    Time frame: up to day 10 postdose

Secondary outcomes

  1. Pharmacokinetics of single subcutaneous and oral doses

    Time frame: up to 10 days postdose

  2. Exploratory evaluation of S-CTX

    Time frame: up to 24 hrs 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, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 25, 2009
Registry last updated
Jan 15, 2010

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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