| Eligibility |
Inclusion Criteria:
Subjects must meet all of the following criteria to be included in this study:
1. Normal, healthy male and female subjects greater than or equal to 18 years of age at
the time of informed consent.
2. All females must have a negative serum human chorionic gonadotropin (hCG) pregnancy
test result at Screening and Baseline. Females of child-bearing potential must agree
to use a medically acceptable method of contraception (e.g., abstinence, an
intrauterine device (IUD), a double-barrier method such as condom + spermicide or
condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or
have a vasectomized partner) throughout the entire study period and for 30 days after
study drug discontinuation. The only subjects who will be exempt from this requirement
are postmenopausal women (defined as greater than age 50 and at least 12 months of
amenorrhea) or subjects who have been sterilized surgically or who are otherwise
proven sterile (e.g., bilateral tubal ligation with surgery at least 6 months prior to
dosing, hysterectomy, or bilateral oophorectomy with surgery at least 2 months prior
to dosing). All women who are of reproductive potential and who are using hormonal
contraceptives must have been on a stable dose of the same hormonal contraceptive
product for at least 12 weeks prior to dosing and must continue to use the same
contraceptive during the study and for 30 days after study drug discontinuation.
3. Male patients who are not abstinent or have undergone a successful vasectomy, who are
partners of women of childbearing potential must use, or their partners must use a
highly affective method of contraception (e.g., condom + spermicide, condom +
diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to
starting study drug(s) and throughout the entire study period and for 30 days (longer
if appropriate) after the last dose of study drug. Those with partners using hormonal
contraceptives must also be using an additional approved method of contraception (as
described previously).
4. Partners of male and female subjects must use an effective method of contraception
(e.g., barrier method, IUD), commencing prior to or at initiation of study drug and
continuing for the duration of the study and for 30 days after study drug
discontinuation. All females who are of reproductive potential and who are using
hormonal contraceptives must have been on a stable dose of the same hormonal
contraceptive product for at least 12 weeks prior to dosing and must continue to use
the same contraceptive during the study and for 30 days after study drug
discontinuation.
5. Voluntarily provide written informed consent prior to any study procedures.
6. Are willing and able to comply with all aspects of the protocol for the duration of
the study.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from participation in the
study:
1. Subjects with any clinically significant abnormality, including a QTc interval of
greater than 450 msec, on 12-lead ECG at the time of the Screening Period, Baseline
Periods, or 30 minutes before administration of study drug.
2. A history of myocardial infarction, syncope or cardiac arrhythmias.
3. A history of uncontrolled hypertension, defined as a systolic pressure of greater than
140 mm Hg and diastolic pressure of greater than 90 mm Hg.
4. A history of unstable heart disease or additional risk factors for Torsades de Pointes
(TdP) including heart failure, hypokalemia, or a family history of congenital long QT
syndrome or unexplained cardiac arrest.
5. Subjects with a history of gastrointestinal surgery (hepatectomy, nephrotomy,
digestive organ resection, etc.) that may affect PK profiles of lenvatinib.
6. Known intolerance to the study drug or moxifloxacin (Avelox) (or any of the
excipients).
7. A positive result from human immunodeficiency virus (HIV), hepatitis A antibody
(HAVAb), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb) tests at
Screening.
8. A known or suspected history of drug or alcohol misuse within 6 months prior to
Screening, or who have a positive urine drug test or breath alcohol test at Screening.
9. Subjects who participated in another clinical trial of an investigational drug or
device within 4 weeks prior to dosing.
10. Subjects who received blood products within 4 weeks, or donated blood within 8 weeks,
or donated plasma within one week of dosing.
11. Subjects who have engaged in heavy exercise within 2 weeks prior to check-in (e.g.,
marathon runners, weight lifters, etc.).
12. Females who are pregnant or breastfeeding.
13. Subjects who are unwilling or unable to abide by the requirements of the study.
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