Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01419990
First received: August 17, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.

During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.


Condition Intervention Phase
Healthy
Drug: GLPG0634
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 Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: From screening up to 10 days after the last dose ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments


Secondary Outcome Measures:
  • Pharmacokinetics (PK) and pharmacodynamics (PD) [ Time Frame: From first dose up to 10 days after the last dose ] [ Designated as safety issue: No ]
    To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD


Enrollment: 16
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLPG0634 capsules Drug: GLPG0634
GLPG0634 300 mg oral capsules, qd, 10 days
Drug: GLPG0634
GLPG0634 450 mg oral capsules, qd, 10 days
Placebo Comparator: Placebo capsules Drug: Placebo
Placebo oral capsules, qd, 10 days

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male, age 40-60 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: NCT01419990

Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium, 2060
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV
Principal Investigator: Lien Gheyle, MD SGS Stuivenberg
  More Information

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01419990     History of Changes
Other Study ID Numbers: GLPG0634-CL-102
Study First Received: August 17, 2011
Last Updated: August 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on August 21, 2014