First-in-Human Single Ascending and Multiple Dose of GLPG... | NCT00905138

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

NCT00905138

Sponsor

Lakefront Biotherapeutics NV

Status

Completed

Last Update Posted

Feb 20, 2012Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy

Interventions

GLPG0259
placebo
GLPG0259
placebo

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

Mar 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

May 19, 2009

First Posted Date

May 20, 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 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.

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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	single ascending doses	Drug: GLPG0259
2	Placebo Comparator	single dose placebo	Drug: placebo
3	Experimental	multiple dose, 5 days, oral solution	Drug: GLPG0259
4	Placebo Comparator	multiple dose, 5 days, oral solution	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLPG0259	Drug	single ascending doses, oral solution	1
placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

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
Eva Vets, MD	SGS Stuivenberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SGS Stuivenberg		Antwerp			Belgium