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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00608699
First received: January 23, 2008
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  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
Dyslipidaemias
 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:

U.S. FDA Resources

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
  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 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:
Flushing
GSK256073A,
Dose Escalation,
Immediate Release Niacin,

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

ClinicalTrials.gov processed this record on May 21, 2013