First-in-Human Exploratory Single Ascending Dose of GLPG0974

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01496937
First received: December 16, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.

Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.


Condition Intervention Phase
Healthy
Drug: GLPG0974
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Double-blind Placebo-controlled Study for the Assessment of Pharmacokinetics (PK), Safety, Tolerability, and Pharmacodynamics (PD) of Single Ascending Oral Doses of GLPG0974 in Healthy Subjects

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • The amount of GLPG0974 in plasma over time after a single oral dose [ Designated as safety issue: No ]
    To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects


Secondary Outcome Measures:
  • Safety and tolerability [ 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

  • Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974 [ Designated as safety issue: No ]
    To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after a single oral dose in healthy subjects


Enrollment: 32
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLPG0974 oral solution
GLPG0974 oral solution
Drug: GLPG0974
Placebo Comparator: Placebo oral solution
Placebo oral solution
Drug: GLPG0974

  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: NCT01496937

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

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01496937     History of Changes
Other Study ID Numbers: GLPG0974-CL-101
Study First Received: December 16, 2011
Last Updated: April 18, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on July 29, 2014