Expired Study
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Baltimore, Maryland 21225


Purpose:

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


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


Study is Available At:


Original ID:

HMA111316


NCT ID:

NCT00608699


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:December 2007
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 26, 2012
First Received Date:January 23, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
Time Frame:up to 8 hours post dose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety and tolerability of GSK256073A and immediate release niacin
Time Frame:up to 36 hours post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacodynamic response
Time Frame:up to 24 hours post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacodynamic response
Time Frame:up to 36 hours post dose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Standard and Secondary pharmacokinetic endpoints of interest
Time Frame:up to 36 hours post dose
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:GSK256073A tablets + IR niacin tablets
Description:single dosing for 4 to 5 sessions
Other Name:GSK256073A tablets + IR niacin tablets

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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