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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01580644

Enrollment

Registered

2012-04-19

Start date

2012-01-31

Completion date

2012-03-31

Last updated

2012-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGGLPG0187 prodrug

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026