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First-in-Human Single Ascending and Multiple Dose of GLPG0634

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ClinicalTrials.gov Identifier: NCT01179581
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 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: GLPG0634 Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Double-blind Placebo-controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG0634 in Healthy Subjects
Study Start Date : August 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
single ascending doses
Drug: GLPG0634
single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)
Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution or capsule (matching corresponding study medication)
Experimental: 3
multiple dose, 10 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).
Drug: GLPG0634
multiple dose, capsule, 10 days
Placebo Comparator: 4
multiple dose, capsules, 10 days; scheme to match that of Study Arm 3.
Drug: placebo
multiple dose, capsule, 10 days


Outcome Measures

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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male, age 40-60 years
  • 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

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): NCT01179581


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01179581     History of Changes
Other Study ID Numbers: GLPG0634-CL-101
2010-018440-14 ( EudraCT Number )
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics