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

Purpose

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

Condition	Intervention	Phase
Healthy Subjects	Drug: GSK256073A tablets + IR niacin tablets	Phase I

Drug Information available for:

Niacin Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-Induced Flushing in Healthy Adult Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Standard and Secondary pharmacokinetic endpoints of interest [ Time Frame: up to 36 hours post dose ]
Pharmacodynamic response [ Time Frame: up to 36 hours post dose ]
Pharmacodynamic response [ Time Frame: up to 24 hours post dose ]

Estimated Enrollment:	24
Study Start Date:	December 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

single dosing for 4 to 5 sessions

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608699

Locations


United States, Maryland
	GSK Investigational Site
	Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	HMA111316
First Received:	January 23, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00608699
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GSK256073A,

Immediate Release Niacin,

Dose Escalation,

Flushing

Study placed in the following topic categories:

Nicotinic Acids

Signs and Symptoms

Flushing

Healthy

Niacin

Additional relevant MeSH terms:

Antimetabolites

Vasodilator Agents

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Growth Substances

Vitamins

Antilipemic Agents

Therapeutic Uses

Physiological Effects of Drugs

Micronutrients

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00608699