Skip to main content
OpenTrials
Completed

NCT Number: NCT01887106

First-in-Human Single and Multiple Dose of GLPG1205

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS LSS Clinical Pharmacology Unit Antwerp

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

Exclusion criteria

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Treatment and study plan

GLPG1205 single ascending doses, oral suspension

Drug

Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg

Placebo single ascending doses, oral suspension

Drug

Single dose, oral suspension matching placebo

GLPG1205, multiple ascending doses, oral suspension

Drug

Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg

Placebo, multiple ascending doses, oral suspension

Drug

Multiple doses, daily for 14 days, oral suspension matching placebo

Primary outcomes

  1. Safety and tolerability after single dose

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

  2. Safety and tolerability after multiple doses

    Time frame: Between screening and 7-10 days after the last dose

    To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

Secondary outcomes

  1. The amount of GLPG1205 in plasma and urine over time after a single oral dose

    Time frame: Between Day 1 predose and 48 hours post dose

    To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects

  2. The amount of GLPG1205 in plasma and urine over time after multiple oral doses

    Time frame: Between Day 1 predose and Day 16 (48 hours after the last dose)

    To characterize the amount of GLPG1205 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects

  3. Ratio of 6-b-hydroxycortisol/cortisol in urine

    Time frame: Twelve hours before dosing on Day 1 and Day 14

    To assess the potential of CYP3A4 induction after repeated dosing with GLPG1205 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine

  4. Receptor occupancy by GLPG1205 on blood cells after a single dose

    Time frame: Day 1 predose up to 24 hours post dose

    To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after a single oral dose in healthy subjects

  5. Receptor occupancy by GLPG1205 on blood cells after multiple doses

    Time frame: Day 1 and Day 14, predose up to 24 hours post dose

    To characterize the pharmacodynamics (PD) of GLPG1205 by means of receptor occupancy by GLPG1205 on blood cells after multiple oral doses in healthy subjects

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled, Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1205 in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
Oct 16, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.