NCT00608699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

January 23, 2008

Last Update Submit

April 26, 2012

Conditions

Healthy SubjectsDyslipidaemias

Keywords

FlushingGSK256073A,Dose Escalation,Immediate Release Niacin,

Outcome Measures

Primary Outcomes (2)

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

    up to 8 hours post dose

  • Safety and tolerability of GSK256073A and immediate release niacin

    up to 36 hours post dose

Secondary Outcomes (3)

  • Standard and Secondary pharmacokinetic endpoints of interest

    up to 36 hours post dose

  • Pharmacodynamic response

    up to 36 hours post dose

  • Pharmacodynamic response

    up to 24 hours post dose

Interventions

GSK256073A tablets + IR niacin tabletsDRUG

single dosing for 4 to 5 sessions

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Flushing

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations

US(1)