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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 23, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date April 30, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Official Title  ICMJE A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Healthy Subjects
  • Dyslipidaemias
Intervention  ICMJE Drug: GSK256073A tablets + IR niacin tablets
single dosing for 4 to 5 sessions
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00608699
Other Study ID Numbers  ICMJE HMA111316
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP