Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Dyslipidaemias

Healthy Subjects

Treatments

Drug: GSK256073A tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00488449

HMA110015

Details and patient eligibility

About

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

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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