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A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval


Phase 1
18 Years
N/A
Not Enrolling
Both
Refractory Solid Tumors, Lymphomas

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Trial Information

A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval


Inclusion Criteria:



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

1. Normal, healthy male and female subjects ≥ 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 >
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 >140 mm Hg
and diastolic pressure of > 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 E7080.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Outcome Measure:

To evaluate the potential for QT/QTc prolongation by 32 mg E7080 using a placebo control and moxifloxacin as the positive control.

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Robert Shumaker

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7080-A001-002

NCT ID:

NCT01525394

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Refractory Solid Tumors
  • Lymphomas
  • lymphomas
  • Refractory solid tumors
  • Lymphoma

Name

Location

Charles RiverTacoma, Washington  98418