GLPG0259 Multiple Ascending Dose and Methotrexate Drug-dr... | NCT00989703

Studies
GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

NCT00989703

Sponsor

Lakefront Biotherapeutics NV

Status

Completed

Last Update Posted

Feb 20, 2012Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

placebo
GLPG0259
Methotrexate

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Oct 2, 2009

First Submission Date that Met QC Criteria

Oct 2, 2009

First Posted Date

Oct 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2012

Last Update Posted Date

Feb 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	GLPG0259 25/50/75 mg/day for 14 days	Drug: GLPG0259 Drug: Methotrexate
2	Placebo Comparator	placebo for 14 days	Drug: placebo Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	oral solution, daily for 14 days	2
GLPG0259

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of oral multiple ascending doses		up to 10 days postdose

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of multiple oral doses		up to 10 days postdose
To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).		up to 10 days postdose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan Beetens, PharmD, PhD	Lakefront Biotherapeutics NV	Study Director
Lien Gheyle, MD	SGS Stuivenberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SGS Stuivenberg		Antwerp			Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D008727	Methotrexate

Ancestor Terms

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided