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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 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:
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins processed this record on March 01, 2015