A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
Summary
To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin
are co-administered as single doses to HVTs.
Clinical Details
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 flushingSafety and tolerability of GSK256073A and immediate release niacin
Secondary outcome: Standard and Secondary pharmacokinetic endpoints of interestPharmacodynamic response Pharmacodynamic response
Eligibility
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
Locations and Contacts
GSK Investigational Site, Baltimore, Maryland 21225, United States
Additional Information
Starting date: December 2007
Last updated: April 26, 2012
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