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Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01580644
First received: April 18, 2012
Last updated: April 19, 2012
Last verified: April 2012

April 18, 2012
April 19, 2012
January 2012
March 2012   (final data collection date for primary outcome measure)
The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug [ Designated as safety issue: No ]
To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects
Same as current
Complete list of historical versions of study NCT01580644 on ClinicalTrials.gov Archive Site
  • The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food [ Designated as safety issue: No ]
    To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug with food in healthy subjects
  • The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food) [ Designated as safety issue: No ]
    To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug at a higher dose (with or without food) in healthy subjects to evaluate dose proportionality
  • Number of adverse events [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of the number of adverse events reported
  • Changes in vital signs as measured by heart rate, blood pressure and body temperature [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported
  • Changes on 12-lead ECG measures [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in 12-ECG measures reported
  • Changes in physical exam measures [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in physical examination reported
  • Changes in blood and urine safety lab parameters [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of the changes in blood and urine safety lab parameters assessed
  • The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food [ Designated as safety issue: No ]
    To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug with food in healthy subjects
  • The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food) [ Designated as safety issue: No ]
    To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug at a higher dose (with or without food) in healthy subjects to evaluate dose proportionality
  • Safety and tolerability [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Not Provided
Not Provided
 
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects

The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects.

Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation.

Furthermore, during the course of the study, safety and tolerability will be characterized.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: GLPG0187 prodrug
  • Experimental: Period 1: formulation 1 oral solution
    Intervention: Drug: GLPG0187 prodrug
  • Experimental: Period 2: formulation 2 capsule
    Intervention: Drug: GLPG0187 prodrug
  • Experimental: Period 3: Selected formulation + food
    Intervention: Drug: GLPG0187 prodrug
  • Experimental: Period 4: Selected formulation at higher dose
    Intervention: Drug: GLPG0187 prodrug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male, age 18-50 years
  • BMI between 18-30 kg/m2

Exclusion Criteria:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01580644
GLPG0187-CL-104
No
Galapagos NV
Galapagos NV
Not Provided
Study Director: Frédéric Vanhoutte, MD Galapagos NV
Principal Investigator: Eva Vets, MD SGS Stuivenberg
Galapagos NV
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP