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

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ClinicalTrials.gov Identifier: NCT00608699
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Dyslipidaemias Drug: GSK256073A tablets + IR niacin tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : December 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: GSK256073A tablets + IR niacin tablets
    single dosing for 4 to 5 sessions


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

Secondary Outcome Measures :
  1. Standard and Secondary pharmacokinetic endpoints of interest [ Time Frame: up to 36 hours post dose ]
  2. Pharmacodynamic response [ Time Frame: up to 36 hours post dose ]
  3. Pharmacodynamic response [ Time Frame: up to 24 hours post dose ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608699


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00608699     History of Changes
Other Study ID Numbers: HMA111316
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by GlaxoSmithKline:
Flushing
GSK256073A,
Dose Escalation,
Immediate Release Niacin,

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