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First-in-Human Single Ascending Dose of GLPG0492

This study has been completed.
Sponsor:
Information provided by:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01130818
First received: May 20, 2010
Last updated: September 20, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: GLPG0492
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 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

Further study details as provided by Galapagos NV:

Primary Outcome Measures:
  • Safety and tolerability of single ascending doses in healthy young and elderly subjects. [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of single oral doses (solution) in young and elderly subjects. [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Determine the maximum tolerated dose in young subjects. [ Time Frame: Up to 10 days postdose ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Senior Vice President Development, Galapagos NV
ClinicalTrials.gov Identifier: NCT01130818     History of Changes
Other Study ID Numbers: GLPG0492-CL-101
Study First Received: May 20, 2010
Last Updated: September 20, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on June 17, 2013