Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

This study is being conducted to determine whether the pharmacokinetics of a single dose of tesetaxel administered as a capsule is affected by co-administration with food (a high-fat meal).

Key inclusion criteria:

• Male or female subjects between 18 and 75 years of age.
• Histologically or cytologically confirmed advanced solid tumor malignancy.
• Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential.
• Agreement to use a highly effective form of contraception throughout the treatment phase of the study in women of childbearing potential and sexually active men.
• Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive.
• 12-lead ECG without any clinically significant abnormality as judged by the Investigator.
• Able to swallow oral medication.
• Adequate organ system function.

Key exclusion criteria:

• A positive pre-study hepatitis B surface antigen.
• Symptomatic or acute hepatic or biliary abnormalities.
• Clinically significant gastrointestinal abnormalities that increase the risk for perforation.
• Presence of uncontrolled infection.
• Positive pre-study drug/alcohol screen.
• 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).
• Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea.
• 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.
• Pregnancy or lactation.
• Hypoalbuminemia (serum albumin <3.0 g/dL) at screening.
• 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.