First-in-Human Single Ascending and Multiple Dose of GLPG0259

Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00905138

Enrollment

Registered

2009-05-20

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2012-02-20

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

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics

Brief summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Interventions

DRUGGLPG0259

single ascending doses, oral solution

DRUGplacebo

single dose, oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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, inclusive.

Exclusion criteria

* significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of single and multiple dosing	up to 10 days postdose

Secondary

Measure	Time frame
Pharmacokinetics of single and repeated doses	up to 10 days postdose
Exploratory evaluation of TNF-alpha and IL6 in whole blood	up to 12 hours postdose

Countries

Belgium

Outcome results

None listed

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