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

Tracking Information

First Received Date ^ICMJE

August 17, 2011

Last Updated Date

August 14, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability [ Time Frame: From screening up to 10 days after the last dose ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01419990 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics (PK) and pharmacodynamics (PD) [ Time Frame: From first dose up to 10 days after the last dose ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: GLPG0634
GLPG0634 300 mg oral capsules, qd, 10 days
Drug: GLPG0634
GLPG0634 450 mg oral capsules, qd, 10 days
Drug: Placebo
Placebo oral capsules, qd, 10 days

Study Arms

Experimental: GLPG0634 capsules
Interventions:
- Drug: GLPG0634
- Drug: GLPG0634
Placebo Comparator: Placebo capsules
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01419990

Other Study ID Numbers ^ICMJE

GLPG0634-CL-102

Has Data Monitoring Committee

Responsible Party

Galapagos NV

Study Sponsor ^ICMJE

Galapagos NV

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Frédéric Vanhoutte, MD	Galapagos NV
Principal Investigator:	Lien Gheyle, MD	SGS Stuivenberg

Information Provided By

Galapagos NV

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP