Last updated: 11/04/2018 08:09:57

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

GSK study ID
HMA111316
Clinicaltrials.gov ID
NCT00608699
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Study to Evaluate the Ability of the HM74A agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
Trial description: To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: up to 8 hours post dose

Safety and tolerability of GSK256073A and immediate release niacin

Timeframe: up to 36 hours post dose

Secondary outcomes:

Standard and Secondary pharmacokinetic endpoints of interest

Timeframe: up to 36 hours post dose

Pharmacodynamic response

Timeframe: up to 36 hours post dose

Pharmacodynamic response

Timeframe: up to 24 hours post dose

Interventions:
  • Drug: GSK256073A tablets + IR niacin tablets
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects, Dyslipidaemias
    Product
    GSK256073
    Collaborators
    Not applicable
    Study date(s)
    December 2007 to April 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Adult males between 18 and 55 years of age, inclusive.
    • Healthy subjects
    • History of significant cardiac arrhythmias
    • Active peptic ulcer disease (PUD) and/or history of PUD
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21225
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-07-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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