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NCT Number: NCT01721980

Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.

Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.

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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 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

GLPG0974

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability

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

    To evaluate the safety and tolerability of GLPG0974 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

Secondary outcomes

  1. The amount of GLPG0974 in plasma and urine over time after multiple oral dose

    Time frame: Between Day 1 predose and Day 14

    To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects

  2. Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974

    Time frame: Day 1 and Day 13, predose until 24h post dose

    To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects

Other outcomes

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

    Time frame: Predose and postdose on Day 1 and Day 13 for 24h

    Potential of CYP3A4 induction by repeated dosing with GLPG0974 will be assessed by means of the ratio of 6b-hydroxycortisol/cortisol in urine

  2. Levels of faecal calprotectin in stool

    Time frame: Prior to first dosing and postdose (between Day 12 and 15)

    Concentrations of faecal calprotectin will be measured as a pharmacodynamic marker in a single stool sample predose and postdose

  3. Glucose and insulin concentrations after glucose loading

    Time frame: Day -1 (predose) and Day 14 (postdose)

    Oral glucose tolerance test by means of measuring concentrations of glucose and insulin after glucose loading, once predosing and once postdosing of GLPG0974

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0974 in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 6, 2012
Registry last updated
Feb 12, 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.

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