A Three-Part Study Of GSK580416 In Healthy Subjects
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study. [ Time Frame: during the study ]
Secondary Outcome Measures
Blood samples to determine drug levels in the body will be collected during the study. [ Time Frame: during the study ]
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy as determined by a physician
Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)
Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
Male and female subjects not willing to follow study specified contraceptive methods
Subjects taking any recreational drugs
Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
Use of St. John's Wort within 28 days before the first dose of study drug
Subjects not willing to follow study specified life style restrictions
Blood donation in excess of 500 mL within a 56 days period