Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419990

Enrollment

Registered

2011-08-19

Start date

2011-08-31

Completion date

2011-10-31

Last updated

2012-08-15

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 the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo. During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

Interventions

DRUGGLPG0634

GLPG0634 300 mg oral capsules, qd, 10 days

DRUGPlacebo

Placebo oral capsules, qd, 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

40 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male, age 40-60 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
Safety and tolerability	From screening up to 10 days after the last dose	To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

Secondary

Measure	Time frame	Description
Pharmacokinetics (PK) and pharmacodynamics (PD)	From first dose up to 10 days after the last dose	To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD

Countries

Belgium

Outcome results

None listed

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