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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

January 23, 2008
April 26, 2012
December 2007
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00608699 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects

To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Healthy Subjects
  • Dyslipidaemias
Drug: GSK256073A tablets + IR niacin tablets
single dosing for 4 to 5 sessions
Other Name: GSK256073A tablets + IR niacin tablets
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00608699
HMA111316
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2012

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