Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01721980
First received: November 2, 2012
Last updated: February 9, 2013
Last verified: February 2013

November 2, 2012
February 9, 2013
October 2012
February 2013   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: Between screening and 7-10 days after the last dose ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01721980 on ClinicalTrials.gov Archive Site
  • The amount of GLPG0974 in plasma and urine over time after multiple oral dose [ Time Frame: Between Day 1 predose and Day 14 ] [ Designated as safety issue: No ]
    To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects
  • 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 ] [ Designated as safety issue: No ]
    To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects
Same as current
  • Ratio of 6b-hydroxycortisol/cortisol in urine [ Time Frame: Predose and postdose on Day 1 and Day 13 for 24h ] [ Designated as safety issue: No ]
    Potential of CYP3A4 induction by repeated dosing with GLPG0974 will be assessed by means of the ratio of 6b-hydroxycortisol/cortisol in urine
  • Levels of faecal calprotectin in stool [ Time Frame: Prior to first dosing and postdose (between Day 12 and 15) ] [ Designated as safety issue: No ]
    Concentrations of faecal calprotectin will be measured as a pharmacodynamic marker in a single stool sample predose and postdose
  • Glucose and insulin concentrations after glucose loading [ Time Frame: Day -1 (predose) and Day 14 (postdose) ] [ Designated as safety issue: Yes ]
    Oral glucose tolerance test by means of measuring concentrations of glucose and insulin after glucose loading, once predosing and once postdosing of GLPG0974
Same as current
 
Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: GLPG0974
  • Drug: Placebo
  • 50 mg GLPG0974 or placebo
    50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
    Interventions:
    • Drug: GLPG0974
    • Drug: Placebo
  • 100 mg GLPG0974 or placebo
    100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
    Interventions:
    • Drug: GLPG0974
    • Drug: Placebo
  • 200 mg GLPG0974 or placebo
    200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
    Interventions:
    • Drug: GLPG0974
    • Drug: Placebo
  • 400 mg GLPG0974 or placebo
    400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
    Interventions:
    • Drug: GLPG0974
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01721980
GLPG0974-CL-102
No
Galapagos NV
Galapagos NV
Not Provided
Study Director: Frédéric Vanhoutte, MD Galapagos NV
Galapagos NV
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP