Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following criteria to be included in this study:

• Normal healthy adult males and females (age 18-45 years).
• Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening.
• Pregnancy or lactation. Female patients of childbearing potential must have a negative pregnancy test before inclusion into the study, and must agree to use medically acceptable methods of contraception (eg, abstinence, condom + spermicide, or a double-barrier method [eg, condom + diaphragm with spermicide], or intrauterine device (IUD), or have a vasectomised partner) starting at Screening and throughout the entire study period and for 2 months after the last dose of study drug. Those female patients using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Cycle 1 Day 1, and continuing throughout the entire study period and for 2 months after the last dose of study drug. Postmenopausal women must have been amenorrheic for at least 12 consecutive months; otherwise a pregnancy test is required. Male patients must agree to use contraceptive methods (eg, abstinence, condom + spermicide or a double-barrier method [eg, condom + partner diaphragm with spermicide]).
• Non-smokers.
• Willing and able to comply with all aspects of the protocol.
• Provide written informed consent.

Exclusion criteria

Participants who meet any of the following criteria will be excluded from this study:

• Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics of study drug.
• Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks of dosing.
• Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history.
• Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determinations at Screening or Baseline.
• An interval corrected for heart rate (QTcF) interval greater than 450 msec at Screening or Baseline.
• Females who are either pregnant or lactating.
• A known or suspected history of drug or alcohol abuse within 6 months prior to screening, or who have a positive urine drug test or alcohol test at Screening or Baseline.
• Positive results for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV) screen.
• Diagnosis of acquired immune deficiency syndrome (AIDS), or positive test for human immunodeficiency virus (HIV).
• Participation in another clinical trial less than 4 weeks prior to dosing or current enrollment in another clinical trial.
• Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week prior to dosing.
• Hemoglobin level less than 12.0 g/dL.
• Known history of any significant drug or food allergy or an ongoing seasonal allergy.
• Use of prescription drugs within 2 weeks prior to Screening (unless drug has a long t1/2, ie, 5 x t1/2 exceeds 2 weeks).
• Use of over-the-counter (OTC) medications within a minimum of 2 weeks prior to dosing.
• Requiring a special diet or taking dietary aids known to modulate drug metabolizing enzymes, or who have consumed foods/beverages or herbal preparations containing Kava root, Ginkgo Biloba Extract (GBE), or St. John's Wort within 4 weeks of Baseline Period 1.
• Known intolerance to the study drug (or any of the excipients).
• Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.