Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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.

• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.

• Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.

• Unwillingness of male subjects to use a condom/spermicide

• Pregnant or nursing women.

• History of flushing (>1 episode annually).

• Fasting blood glucose 110 mg/dl and/or history of type I or type II DM

• History of intra-ocular pathology

• History of recurrent gum bleeding

• History of bleeding haemorrhoids