Repeat Dose Food Effect Study of GSK256073F in Healthy Adult Subjects (NCT00808093) | Clinical Trial Compass
CompletedPhase 1
Repeat Dose Food Effect Study of GSK256073F in Healthy Adult Subjects
United States30 participantsStarted 2008-05-12
Plain-language summary
The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Male or female of non-childbearing potential between 18 and 55 years of age.
* A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\].
* Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post-last dose.
* Body weight \> 50 kg (110 pounds) and BMI within the range 19 - 31 kg/m2 (inclusive).
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* QTcB or QTcF \< 450 msec
Exclusion Criteria:
* The subject has a positive pre-…
What they're measuring
1
1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions
Timeframe: throughout study
2
2. AUC0-inf, Cmax, and Ctrough (Ct) under fed conditions