Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by:

Galapagos NV

ClinicalTrials.gov Identifier:

NCT01208753

First received: September 23, 2010

Last updated: March 22, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 23, 2010

Last Updated Date

March 22, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of multiple dosing [ Time Frame: Daily during treatment, up to 10 days postdose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01208753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics of repeated doses [ Time Frame: 24 hours postdose ] [ Designated as safety issue: No ]
Pharmacodynamics (PD) of GLPG0555 after repeated oral administration [ Time Frame: up to 10 days postdose ] [ Designated as safety issue: No ]
The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days [ Time Frame: up to 24 hours postdose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 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 Doses of GLPG0555 in Healthy Subjects.

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

Detailed Description

Not Provided

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)

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: GLPG0555
two different aqueous formulations
Drug: GLPG0555 aqueous
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
Drug: placebo
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Study Arm (s)

Experimental: Aqueous formulations for formulation selection
50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation

Intervention: Drug: GLPG0555
Experimental: GLPG0555 ascending doses
multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily)

Intervention: Drug: GLPG0555 aqueous
Placebo Comparator: 3
once or twice daily for 13 days, matching the scheme of the multiple ascending dose.

Intervention: Drug: placebo

Publications *

Not Provided

* 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

February 2011

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 50 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

NCT01208753

Other Study ID Numbers ^ICMJE

GLPG0555-CL-102, 2010-018570-20

Has Data Monitoring Committee

Responsible Party

Senior Vice President Development, Galapagos NV

Study Sponsor ^ICMJE

Galapagos NV

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Gerben van 't Klooster, PhD	Galapagos NV
Principal Investigator:	Wouter Haazen, MD	SGS Stuivenberg

Information Provided By

Galapagos NV

Verification Date

March 2011

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

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