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GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01336244
First received: April 13, 2011
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.


Condition Intervention Phase
Healthy
Drug: GLPG0778
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)
Official Title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: Daily during treatment, up to 10 days postdose ] [ Designated as safety issue: No ]
    At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.

  • Evaluation of hematological, biochemical and cardiovascular parameters. [ Time Frame: until 10 days postdose. ] [ Designated as safety issue: No ]
    On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.


Secondary Outcome Measures:
  • Pharmacokinetics of repeated doses [ Time Frame: 24 hours postdose ] [ Designated as safety issue: No ]
    Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).

  • Pharmacodynamics (PD) of GLPG0778 [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
    To explore biomarkers of GLPG0778 activity after repeated oral administrations.


Enrollment: 45
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLPG0778 ascending doses
Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.
Drug: GLPG0778
capsules containing 50 or 100 mg of GLPG0778
Placebo Comparator: Placebo
Twice daily for 13 days, matching the scheme of the multiple ascending dose.
Drug: placebo
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

  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
  • body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria:

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse
  • hypersensitivity to any of the test substances
  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: NCT01336244

Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Gerben van 't Klooster, PhD Galapagos NV
Principal Investigator: Lien Gheyle, MD SGS Stuivenberg
  More Information

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01336244     History of Changes
Other Study ID Numbers: GLPG0778-CL-102, 2011-000892-16
Study First Received: April 13, 2011
Last Updated: October 17, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics

ClinicalTrials.gov processed this record on November 20, 2014