Status:
COMPLETED
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Dyslipidaemias
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00608699
Start Date
December 1 2007
End Date
April 1 2008
Last Update
April 30 2012
Active Locations (1)
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1
GSK Investigational Site
Baltimore, Maryland, United States, 21225