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

Condition(s) targeted: Healthy Subjects; Dyslipidaemias

Intervention: GSK256073A tablets + IR niacin tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Official title: A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Primary outcome:

Intensity of reported flushing - visual analogue scale; self reported assessment of flushing

Safety and tolerability of GSK256073A and immediate release niacin

Secondary outcome:

Standard and Secondary pharmacokinetic endpoints of interest

Pharmacodynamic response

Pharmacodynamic response

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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

GSK Investigational Site, Baltimore, Maryland 21225, United States

Starting date: December 2007
Last updated: April 26, 2012