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First-in-Human Single Ascending and Multiple Dose of GLPG0778

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01278108
First received: January 14, 2011
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


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 Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Oral Doses, and Multiple Oral Doses of GLPG0778 in Healthy Subjects.

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of single and multiple dosing [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
    Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.


Secondary Outcome Measures:
  • Pharmacokinetics of single and repeated doses, including effect of food. [ Time Frame: up to 10 days 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).


Estimated Enrollment: 40
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
single ascending doses
 Drug: GLPG0778
single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)
Placebo Comparator: 2
single dose placebo
 Drug: placebo
single dose, oral solution or capsule (matching corresponding study medication)
Experimental: 3
multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).
 Drug: GLPG0778
multiple dose, capsule, 7 days
Placebo Comparator: 4
multiple dose, capsules, 7 days; scheme to match that of Study Arm 3.
 Drug: placebo
multiple dose, capsule, 7 days

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • any condition that might interfere with the procedures or tests in the study
  • smoking
  • drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278108

Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium, 2060
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: NCT01278108     History of Changes
Other Study ID Numbers: GLPG0778-CL-101, 2010-023199-16
Study First Received: January 14, 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 May 21, 2013