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

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01179581
First received: August 10, 2010
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Healthy
Drug: GLPG0634
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 Single and Multiple Ascending Oral Doses of GLPG0634 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).


Enrollment: 48
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders 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
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: 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

No publications provided

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
Study First Received: August 10, 2010
Last Updated: March 23, 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 October 23, 2014