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

April 26, 2012 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
Time Frame: up to 8 hours post dose
up to 8 hours post dose
Safety and tolerability of GSK256073A and immediate release niacin
Time Frame: up to 36 hours post dose
up to 36 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Standard and Secondary pharmacokinetic endpoints of interest
Time Frame: up to 36 hours post dose
up to 36 hours post dose
Pharmacodynamic response
Time Frame: up to 36 hours post dose
up to 36 hours post dose
Pharmacodynamic response
Time Frame: up to 24 hours post dose
up to 24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMA111316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe