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

Phase 1

Completed

• Conditions: Healthy Subjects; Dyslipidaemias

• Registration Number: NCT00608699
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-06
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Standard and Secondary pharmacokinetic endpoints of interest	up to 36 hours post dose
Pharmacodynamic response	up to 24 hours post dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Baltimore, Maryland, United States