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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: GLPG0974
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 32
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
50 mg GLPG0974 or placebo
50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
Drug: GLPG0974 Drug: Placebo
100 mg GLPG0974 or placebo
100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days
Drug: GLPG0974 Drug: Placebo
200 mg GLPG0974 or placebo
200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
Drug: GLPG0974 Drug: Placebo
400 mg GLPG0974 or placebo
400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days
Drug: GLPG0974 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721980

Locations
Belgium
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV
  More Information

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01721980     History of Changes
Other Study ID Numbers: GLPG0974-CL-102
Study First Received: November 2, 2012
Last Updated: February 9, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on September 22, 2014