Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0187 prodrug

• Registration Number: NCT01580644
• Lead Sponsor: Galapagos NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 2: formulation 2 capsule	GLPG0187 prodrug	-
Period 1: formulation 1 oral solution	GLPG0187 prodrug	-
Period 3: Selected formulation + food	GLPG0187 prodrug	-
Period 4: Selected formulation at higher dose	GLPG0187 prodrug	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium