First-in-Human Single Ascending and Multiple Dose of GLPG0259

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT00905138
First received: May 18, 2009
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Condition Intervention Phase
Healthy
Drug: GLPG0259
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 Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 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: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of single and repeated doses [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • Exploratory evaluation of TNF-alpha and IL6 in whole blood [ Time Frame: up to 12 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
single ascending doses
Drug: GLPG0259
single ascending doses, oral solution
Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution
Experimental: 3
multiple dose, 5 days, oral solution
Drug: GLPG0259
multiple dose, oral solution, 5 days
Placebo Comparator: 4
multiple dose, 5 days, oral solution
Drug: placebo
oral solution, 5 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, age 18-50 years
  • BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

  • significantly abnormal platelet function or coagulopathy
  • 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: NCT00905138

Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Johan Beetens, PharmD, 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: NCT00905138     History of Changes
Other Study ID Numbers: GLPG0259-CL-101
Study First Received: May 18, 2009
Last Updated: February 17, 2012
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 22, 2014