Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Subjects, Dyslipidaemias

In brief

The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.

Key facts

Study ID

NCT00488449

Run by

GlaxoSmithKline

People needed

56

Starts

2007-06-01

Expected to finish

2007-11-01

Last updated by the study team

2012-06-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Adult males or females between 18 and 55 years of age, inclusive.
• Female subjects must be of non-childbearing potential
• Body weight > 50 kg (110 pounds) and body mass index (BMI) 19 and 31 where:
• Subjects with QTc < 450 msec at screening (or QTc < 480 msec for subjects with Bundle Branch Block).
• A signed and dated written informed consent prior to admission to the study.
• The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restriction

You may not qualify if…

• Systolic blood pressure < 100 mmHg or 150 mmHg and/or diastolic blood pressure = 100 mmHg at screening.
• History of significant cardiac arrhythmias
• Active peptic ulcer disease (PUD) and/or history of PUD within 1 year.
• A serum uric acid concentration 8mg/dL
• Screening test positive for H. Pylori using the non-radioactive breath test
• History of gout and/or hyperuricemia
• History of Gilbert's syndrome
• A serum creatinine concentration above the normal reference range
• History of kidney stones
• PT and/or aPTT above the reference range
• History of recurrent indigestion, stomach upset or diarrhea
• Liver function tests (LFTs) or creatinine phosphokinase (CPK) 1.5X ULN
• Screening stool test positive for occult blood
• Screening peripheral blood smear with abnormal RBCs
• CBC, MCV, and/or reticulocyte count corrected for haemoglobin level above the reference range at screening
• Reduced G6PD activity
• Serum haptoglobin outside the reference range at screening
• Total serum LDH > 1.25% above the ULN at screening
• Positive HIV, Hepatitis B or Hepatitis C at screening
• The subject has a positive pre-study urine drug/ serum alcohol screen.
• History of alcohol consumption exceeding, on average, 7 drinks/week for women or 14 drinks/week for men within 6 months of the first dose of study medication or a positive alcohol test at screening
• History of use of tobacco or nicotine containing products within 6 months of screening or a positive urine cotinine screen
• Use of prescription (including hormone replacement therapy) or non-prescription drugs and vitamins within 7 days or 5 half-lives prior to administration of study medication. An exception is acetaminophen which is allowed at doses of 2g/day.
• Use of dietary/herbal supplements within 14 days prior to treatment with study medication
• Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing.

Where it is running

• GSK Investigational Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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