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First-in-Human Single Ascending Dose of GLPG0492

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ClinicalTrials.gov Identifier: NCT01130818
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG0492 Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 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 and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects
Study Start Date : May 2010
Primary Completion Date : August 2010
Study Completion Date : September 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
single ascending doses
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
Placebo Comparator: 2
single dose placebo
Drug: placebo
single dose, oral solution
Experimental: 3
single dose, oral solution, 50 mg
Drug: GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
Experimental: 4
single dose, capsules (fasting)
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
Experimental: 5
single dose, capsules (fed)
Drug: GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability of single ascending doses in healthy young and elderly subjects. [ Time Frame: up to 10 days postdose ]

Secondary Outcome Measures :
  1. Pharmacokinetics of single oral doses (solution) in young and elderly subjects. [ Time Frame: up to 10 days postdose ]
  2. Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food. [ Time Frame: up to 10 days postdose ]
  3. Determine the maximum tolerated dose in young subjects. [ Time Frame: Up to 10 days postdose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)
  • BMI between 18-30 kg/m², inclusive
  • non-smoker

Exclusion Criteria:

  • elevated PSA
  • 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): NCT01130818


Locations
Belgium
SGS Stuivenberg
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Florence Namour, PhD Galapagos NV
Principal Investigator: Sofie Mesens, MD SGS Stuivenberg
More Information

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01130818     History of Changes
Other Study ID Numbers: GLPG0492-CL-101
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Galapagos NV:
Safety
Tolerability
Pharmacokinetics
Bioavailability (solid vs solution, fasting vs fed)
Young healthy subjects
Elderly healthy subjects

Additional relevant MeSH terms:
Pharmaceutical Solutions