Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

Exclusion Criteria

• •1. A positive pre-study hepatitis B surface antigen.
• •2. Symptomatic or acute hepatic or biliary abnormalities.
• •3. Clinically significant gastrointestinal abnormalities that increase the risk for perforation.
• •4. Presence of uncontrolled infection.
• •5. Positive pre-study drug/alcohol screen.
• •6. Treatment with an investigational agent within the following time periods prior to the first dose of study drug: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longest).
• •7. Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea.
• •8. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with a subject's safety, obtaining informed consent, or compliance with the study.
• •9. Pregnancy or lactation.
• •10. Hypoalbuminemia (serum albumin \<3.0 g/dL) at screening.
• •11. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, and/or pummelos, exotic citrus fruits, or grapefruit hybrids within 14 days prior to the first dose of study drug.