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NCT01580644 Clinical Trial

Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers

Healthy Clinical Trial

Official title:
Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01580644
Other study ID # GLPG0187-CL-104
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2012
Last updated April 19, 2012
Start date January 2012
Est. completion date March 2012

Study information
Verified date April 2012
Source Galapagos NV
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GLPG0187 prodrug

Locations
Country Name City State
Belgium SGS Stuivenberg Antwerp

Sponsors (1)
Lead Sponsor Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug 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 No
Secondary The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food 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 No
Secondary 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) 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 No
Secondary Number of adverse events 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 Yes
Secondary Changes in vital signs as measured by heart rate, blood pressure and body temperature 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 Yes
Secondary Changes on 12-lead ECG measures 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 Yes
Secondary Changes in physical exam measures 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 Yes
Secondary Changes in blood and urine safety lab parameters 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 Yes
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