A Study To See If GSK256073A Can Block Niacin-Induced Flu... | NCT00608699

Studies
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers

NCT00608699

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Apr 30, 2012Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Subjects
Dyslipidaemias

Interventions

GSK256073A tablets + IR niacin tablets

Countries

United States

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

Apr 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

Dec 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 23, 2008

First Submission Date that Met QC Criteria

Feb 5, 2008

First Posted Date

Feb 6, 2008Estimated

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

Apr 26, 2012

Last Update Posted Date

Apr 30, 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

To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.

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

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK256073A tablets + IR niacin tablets	Drug	single dosing for 4 to 5 sessions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing		up to 8 hours post dose
Safety and tolerability of GSK256073A and immediate release niacin		up to 36 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Standard and Secondary pharmacokinetic endpoints of interest		up to 36 hours post dose
Pharmacodynamic response		up to 36 hours post dose
Pharmacodynamic response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult males between 18 and 55 years of age, inclusive.
Healthy subjects
Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
Subjects with QTc < 450 msec at screening

Exclusion Criteria:

History of significant cardiac arrhythmias
Active peptic ulcer disease (PUD) and/or history of PUD
History of gout and/or hyperuricemia
History of Gilbert's syndrome
History of recurrent indigestion, stomach upset or diarrhea
History of other than rare (once yearly or less) flushing
Recurrent skin rash or psoriasis
History of kidney stones

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Baltimore	Maryland	21225	United States

Condition Browse Module

MeSH Terms

ID	Term
D005483	Flushing

Ancestor Terms

ID	Term
D012877	Skin Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided