Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: GLPG0187 prodrug	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects

Further study details as provided by Galapagos NV:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	12
Study Start Date:	January 2012
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Period 1: formulation 1 oral solution	Drug: GLPG0187 prodrug
Experimental: Period 2: formulation 2 capsule	Drug: GLPG0187 prodrug
Experimental: Period 3: Selected formulation + food	Drug: GLPG0187 prodrug
Experimental: Period 4: Selected formulation at higher dose	Drug: GLPG0187 prodrug

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580644

Locations

Belgium
SGS Stuivenberg
Antwerp, Belgium

Sponsors and Collaborators

Galapagos NV

Investigators

Study Director:	Frédéric Vanhoutte, MD	Galapagos NV
Principal Investigator:	Eva Vets, MD	SGS Stuivenberg

More Information

No publications provided

Responsible Party:	Galapagos NV
ClinicalTrials.gov Identifier:	NCT01580644 History of Changes
Other Study ID Numbers:	GLPG0187-CL-104
Study First Received:	April 18, 2012
Last Updated:	April 19, 2012
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on May 16, 2013