Back to resultsA Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Primary Purpose
Healthy Subjects, Dyslipidaemias
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK256073A tablets + IR niacin tablets
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy Subjects focused on measuring Flushing, GSK256073A,, Dose Escalation,, Immediate Release Niacin,
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
Safety and tolerability of GSK256073A and immediate release niacin
Secondary Outcome Measures
Standard and Secondary pharmacokinetic endpoints of interest
Pharmacodynamic response
Pharmacodynamic response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00608699
Brief Title
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
Official Title
A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Dyslipidaemias
Keywords
Flushing, GSK256073A,, Dose Escalation,, Immediate Release Niacin,
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK256073A tablets + IR niacin tablets
Intervention Description
single dosing for 4 to 5 sessions
Primary Outcome Measure Information:
Title
Intensity of reported flushing - visual analogue scale; self reported assessment of flushing
Time Frame
up to 8 hours post dose
Title
Safety and tolerability of GSK256073A and immediate release niacin
Time Frame
up to 36 hours post dose
Secondary Outcome Measure Information:
Title
Standard and Secondary pharmacokinetic endpoints of interest
Time Frame
up to 36 hours post dose
Title
Pharmacodynamic response
Time Frame
up to 36 hours post dose
Title
Pharmacodynamic response
Time Frame
up to 24 hours post dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
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A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers
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