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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608699
• Other study ID #: HMA111316
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2008
• Last updated: April 26, 2012
• Start date: December 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidaemias
• Dyslipidemias
• Flushing
• Healthy Subjects

Intervention

Drug:
• GSK256073A tablets + IR niacin tablets
single dosing for 4 to 5 sessions

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of reported flushing - visual analogue scale; self reported assessment of flushing		up to 8 hours post dose
Primary	Safety and tolerability of GSK256073A and immediate release niacin		up to 36 hours post dose
Secondary	Standard and Secondary pharmacokinetic endpoints of interest		up to 36 hours post dose
Secondary	Pharmacodynamic response		up to 36 hours post dose
Secondary	Pharmacodynamic response		up to 24 hours post dose