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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Dyslipidaemias; Healthy Subjects

Treatments: Drug: GSK256073A tablets + IR niacin tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00608699

HMA111316

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind