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Completed

NCT Number: NCT00608699

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

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

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Key information

Conditions

Healthy Subjects Dyslipidaemias Flushing Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK256073A tablets + IR niacin tablets

Drug

single dosing for 4 to 5 sessions

Primary outcomes

  1. Intensity of reported flushing - visual analogue scale; self reported assessment of flushing

    Time frame: up to 8 hours post dose

  2. Safety and tolerability of GSK256073A and immediate release niacin

    Time frame: up to 36 hours post dose

Secondary outcomes

  1. Standard and Secondary pharmacokinetic endpoints of interest

    Time frame: up to 36 hours post dose

  2. Pharmacodynamic response

    Time frame: up to 36 hours post dose

  3. Pharmacodynamic response

    Time frame: up to 24 hours post dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2008
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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