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E7080 Food Effect Study in Healthy Subjects

Phase 1
18 Years
55 Years
Not Enrolling

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Trial Information

E7080 Food Effect Study in Healthy Subjects

Inclusion Criteria:

1. Healthy, male or female subjects age ≥ 18 years and ≤ 55 years old;

2. Body mass index (BMI) >18 and ≤ 32 kg/m2 at Screening;

3. All females must have a negative serum β-human chorionic gonadotropin (ß-hCG) test
result or negative urine pregnancy test results at Screening and Baseline. Females of
child-bearing potential must agree to use a medically acceptable method of
contraception (eg, abstinence, an intrauterine device, a double-barrier method such
as condom + spermicide or condom + diaphragm with spermicide, a contraceptive
implant, an oral contraceptive or have a vasectomised 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 with at least 12 months of amenorrhea) or subjects who have been
sterilized surgically or who are otherwise proven sterile (eg, 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;

4. Male subjects who are partners of women of childbearing potential must use, or their
partners must use a highly effective method of contraception (eg, condom +
spermicide, condom + diaphragm with spermicide, intrauterine device (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);

5. Provide written informed consent;

6. Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

1. 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;

2. A clinically significant illness within 8 weeks or a clinically significant infection
within 4 weeks, of dosing;

3. Evidence of organ dysfunction or any clinically significant deviation from normal in
their medical history;

4. History of clinically significant drug or food allergies or presently experiencing
seasonal allergies;

5. Evidence of clinically significant deviation from normal in physical examination,
vital signs, electrocardiograms (ECG) or clinical laboratory determinations at
Screening or Baseline;

6. Clinically significant ECG abnormality including a marked baseline prolongation of
QT/QTc interval (eg repeated demonstration of a QTc interval > 500 msec), or a family
history of prolonged QTc syndrome or sudden death;

7. History of drug or alcohol misuse within 6 months prior to Screening, or who have a
positive urine drug test at Screening or Baseline;

8. Positive result for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV)
screen, or a positive syphilis screen;

9. Diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human
immunodeficiency virus (HIV);

10. Participated in another clinical trial less than 4 weeks prior to dosing or who are
currently enrolled in another clinical trial;

11. Consumed caffeinated beverages or food within 72 hours prior to dosing;

12. Consumed grapefruit or grapefruit containing beverages or food within 72 hours prior
to dosing;

13. Experienced a weight loss or gain of > 10% within 4 weeks of dosing;

14. Engaged in heavy exercise (≥ 1 hour/day 5 times/week) less than 2 weeks prior to
Baseline (eg, marathon runners, weight lifters, etc.);

15. Received blood products within 4 weeks, or donated blood within 8 weeks, or donated
plasma within 1 week, of dosing;

16. Hemoglobin level less than 12.0 g/dL;

17. Used prescription drugs within 2 weeks prior to screening;

18. Taken over-the-counter (OTC) medications within 2 weeks prior to dosing;

19. Any condition that would make him/her in the opinion of the Investigator or Sponsor,
unsuitable for the study or who, in the opinion of the Investigator, is not likely to
complete the study for any reason;

20. Inability to tolerate venepuncture and/or venous access;

21. History of depression, deliberate self harm or suicidal ideation.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the effect of food on the bioavailability of E7080.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Eisai Inc.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Cancer



Charles River Clinical Studies, NWTacoma, Washington  98418