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

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ClinicalTrials.gov Identifier: NCT01278108
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: GLPG0778 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety and tolerability of single and multiple dosing [ Time Frame: up to 10 days postdose ]
    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 :
  1. Pharmacokinetics of single and repeated doses, including effect of food. [ Time Frame: up to 10 days postdose ]
    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).



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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
  • 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

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): 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

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01278108     History of Changes
Other Study ID Numbers: GLPG0778-CL-101
2010-023199-16 ( EudraCT Number )
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics