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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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