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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 23, 2008
Last updated: April 26, 2012
Last verified: April 2012

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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects

Resource links provided by NLM:

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 ]

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

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

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

United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00608699     History of Changes
Other Study ID Numbers: HMA111316
Study First Received: January 23, 2008
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dose Escalation,
Immediate Release Niacin,

Additional relevant MeSH terms:
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014