A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-14 (14C)E7386 in Healthy Male Participants

NCT ID: NCT05607537

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2023-08-31

Brief Summary

The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg [microgram]) solution for Part 1 and to determine the pharmacokinetic (PK) and excretion of E7386 following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part 2.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1: E7386 40 mg Tablet + (14C)E7386

Participants will be administered a single oral dose of E7386 40 mg tablet on Day 1 followed by an intravenous infusion containing a microdose solution of \[14C\]E7386 (100 mcg) with not more than (NMT) 7.4 kilobecquerel (kBq) (0.20 microcurie \[mcCi\]), starting approximately 25 minutes post oral dose administered as 5 milliliter (mL) over 5 minutes to coincide with the time at which the highest drug concentration occurs (tmax) for E7386 after an oral dose.

Group Type: EXPERIMENTAL

E7386 Tablet

Intervention Type: DRUG

E7386 40 mg tablet.

(14C)E7386

Intervention Type: DRUG

(14C)E7386 administered intravenously.

Part 2: (14C)E7386 40 mg Capsule

Participants will be administered a single oral dose of E7386 40 mg capsule radiolabeled with approximately 2.96 megabecquerel (MBq) (80 mcCi) (14C)E7386 (final dose to depend on the specific activity of \[14C\]E7386) in the morning on Day 1 after an overnight fasting.

Group Type: EXPERIMENTAL

(14C)E7386 Capsule

Intervention Type: DRUG

(14C)E7386 40 mg capsule.

Interventions

E7386 Tablet

E7386 40 mg tablet.

Intervention Type: DRUG

(14C)E7386 Capsule

(14C)E7386 40 mg capsule.

Intervention Type: DRUG

(14C)E7386

(14C)E7386 administered intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Non-smoking, healthy male, age greater than or equal to (>=) 30 years and less than or equal to (<=) 55 years old at the time of informed consent

2. Body Mass Index (BMI) of greater than (>) 18 to less than (<) 30 kilogram per square meter (kg/m^2) as measured at Screening

3. Adequate organ function per blood work

4. Participant must have regular bowel movements (that is, average stool production of >=1 and <=3 stools per day)

5. Participant must agree to adhere to the contraception requirements

Exclusion Criteria

1. Have participated in any clinical research study involving nonradiolabeled investigational product within 90 days prior to Day -1 (Baseline) or involving radiolabeled investigational product within 12 months prior to Day -1 (Baseline)

2. Participant has had exposure to significant diagnostic or therapeutic radiation (example, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1 (Baseline)

3. Male participant with pregnant or breastfeeding partner

4. Male participant who is unwilling to follow the contraception rules of the study for up to 92 days after last dose of the study drug

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

6. A prolonged QT/QTc interval (QTcF [corrected QT interval by Fridericia] >450 millisecond [ms]) as confirmed by a repeated ECG at Screening or Baseline, or a history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome), or the use of concomitant medications that prolonged the QT/QTc interval

7. Known history of clinically significant drug, food allergies, or presently experiencing any seasonal or perennial allergy at Screening and Baseline (Day -1)

8. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus (HIV) antibody at Screening

9. History of recreational drug use, drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or admission

10. Participant who is, or is an immediate family member of, a study site or sponsor employee

11. Participant does not have suitable veins for multiple venipunctures/cannulations as assessed by the investigator or delegate at Screening

12. Receipt of blood products within 4 weeks prior to dosing, or donation of blood or plasma within the previous 3 months, or loss of greater than 400 mL of blood

13. Any history of or concomitant medical condition that in the opinion of the investigator would compromise the participant's ability to safely complete the study at Screening and Day -1 (Baseline)

14. Failure to satisfy the investigator of fitness to participate for any other reason

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Labcorp Clinical Research Unit

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

2022-000954-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7386-E044-003

Identifier Type: -

Identifier Source: org_study_id