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

NCT ID: NCT00608699

Last Updated: 2012-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-04-30

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.

Conditions

Healthy Subjects; Dyslipidaemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

GSK256073A tablets + IR niacin tablets

single dosing for 4 to 5 sessions

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HMA111316

Identifier Type: -

Identifier Source: org_study_id