A Food-Effect Study of E7386 in Healthy Participants

Food Effect in Healthy Participants Clinical Trial

Official title:

A Phase 1 Food-Effect Study of E7386 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996226
• Other study ID #: E7386-A001-001
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: June 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Non-smoking, healthy participants at the time of informed consent.

2. Body Mass Index (BMI) greater than (>) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) at Screening.

Exclusion Criteria:

1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 international units per litre (IU/L) or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug

2. Females of childbearing potential who:

• Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:

1. total abstinence (if it is their preferred and usual lifestyle)

2. an intrauterine device or intrauterine hormone-releasing system

3. a contraceptive implant

4. an oral contraceptive (with additional barrier method) (Participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation)

5. have a vasectomized partner with confirmed azoospermia

• Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)

3. Males who have not had a successful vasectomy (confirmed azoospermia) and their female partners meet the exclusion criteria No: 2, above. If the female partner is pregnant, then males who do not agree to use Barrier contraception (latex or synthetic condoms) throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation

4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing

5. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism

6. Any history of major surgery, e.g., intestinal resections, hepatectomy, nephrectomy, digestive organ resection that may affect absorption, metabolism or excretion of E7386.

7. Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening

8. Clinically significant ECG abnormality including a marked baseline prolongation of QT/corrected QT interval (QTc) (example: repeated demonstration of a QTc interval greater than (>) 500 milliseconds [msec]), or a family history of prolonged QTc syndrome or sudden death

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

10. Diagnosed with acquired immune deficiency syndrome, or test positive for human immunodeficiency virus (HIV) at screening

11. Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening

12. Use of prescription drugs within 4 weeks prior to dosing

13. Intake of over-the-counter medications within 2 weeks prior to dosing

14. Intake of caffeinated beverages or food within 72 hours prior to dosing

15. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing

16. Participated in another clinical trial less than 4 weeks prior to dosing or was currently enrolled in another clinical trial

17. Consumed grapefruit, starfruit, Seville oranges or their products within 7 days prior to dosing

18. Consumed herbal preparations/medications including but not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng within 7 days prior to dosing

19. Allergic to E7386 or any of the tablet's ingredients

20. Known history of clinically significant drug or food allergies, or presently experiencing significant seasonal or perennial allergy at Screening.

Related Conditions & MeSH terms

• Food Effect in Healthy Participants

Intervention

Drug:
• E7386
E7386 oral tablets.

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for E7386		Day 1: 0-48 hours; Day 8: 0-48 hours
Primary	Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for E7386		Day 1: 0-48 hours; Day 8: 0-48 hours
Primary	AUC0-t: AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for E7386		Day 1: 0-48 hours; Day 8: 0-48 hours
Primary	AUC0-inf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for E7386		Day 1: 0-48 hours; Day 8: 0-48 hours