Dyslipidaemias, Healthy Subjects
Conditions
Keywords
Flushing, GSK256073A,, Dose Escalation,, Immediate Release Niacin,
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.
Interventions
DRUGGSK256073A tablets + IR niacin tablets
single dosing for 4 to 5 sessions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of reported flushing - visual analogue scale; self reported assessment of flushing | up to 8 hours post dose |
| Safety and tolerability of GSK256073A and immediate release niacin | up to 36 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Standard and Secondary pharmacokinetic endpoints of interest | up to 36 hours post dose |
| Pharmacodynamic response | up to 36 hours post dose |
Countries
United States
Outcome results
None listed