Study of the Absolute Oral Bioavailability of BMS-791325 in Healthy Subjects
Study of the Absolute Oral Bioavailability of BMS-791325 in Healthy Subjects
The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.
Primary Purpose: Other: Protocol is designed to assess the absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally
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Inclusion Criteria:
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Men and women ages 18 to 49 years, inclusive
Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding
Exclusion Criteria:
i)PR ≥ 210 msec
ii)QRS ≥ 120 msec
iii)QT ≥ 500 msec
iv)QTcF ≥ 450 msec
v)Second or third degree heart block
h) Positive urine screen for drugs of abuse
i) Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, r HIV-1, -2 antibodies
j) Any of the following screening or Day -1 laboratory results outside the ranges specified below as defined by the laboratory, confirmed by repeat analysis:
i)Serum creatinine > upper limit of normal (ULN)
ii)Alanine aminotransferase (ALT) > ULN
iii)Aspartate aminotransferase(AST) > ULN
iv)Total bilirubin > ULN
k) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)