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First-in-Human Exploratory Single Ascending Dose of GLPG0974

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ClinicalTrials.gov Identifier: NCT01496937
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: GLPG0974 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: GLPG0974 oral solution
GLPG0974 oral solution
Drug: GLPG0974
Placebo Comparator: Placebo oral solution
Placebo oral solution
Drug: GLPG0974



Primary Outcome Measures :
  1. The amount of GLPG0974 in plasma over time after a single oral dose
    To characterize the amount of GLPG0974 in plasma over time - pharmacokinetics (PK) - after a single oral dose in healthy subjects


Secondary Outcome Measures :
  1. Safety and tolerability
    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

  2. Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974
    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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01496937     History of Changes
Other Study ID Numbers: GLPG0974-CL-101
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Pharmaceutical Solutions