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

Eisai Limited15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

E7386 TabletDRUG

E7386 40 mg tablet.

(14C)E7386 CapsuleDRUG

(14C)E7386 40 mg capsule.

(14C)E7386DRUG

(14C)E7386 administered intravenously.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Labcorp Clinical Research Unit

Leeds, United Kingdom

Outcomes

Primary Outcomes

Part 1, %F: Percent Absolute Oral Bioavailability for (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 96 hours post-dose

Part 1, Cmax: Maximum Observed Plasma Concentration for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 96 hours post-dose

Part 1, Tlag: Time Delay Between Drug Administration and the Onset of Absorption for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 96 hours post-dose

Part 1, Tmax: Time to Reach Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 96 hours post-dose

Part 1, AUC(0-12h): Area Under the Plasma Concentration-time Curve From Time Zero to 12 hours Post-dose for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 12 hours post-dose

Part 1, AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time Zero to 24 hours Post-dose for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 24 hours post-dose

Part 1, AUC(0-last): Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Measurable Concentration for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 96 hours post-dose

Part 1, AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time for Total Radioactivity, (14C)E7386 and E7386

Time frame: Pre-dose (0 hour) up to 96 hours post-dose

Part 1, t1/2: Apparent Terminal Elimination Phase Half-life for Total Radioactivity, (14C)E7386 and E7386

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Part 2 (Metabolic Profile of E7386): Concentration of Metabolite of E7386 in Plasma, Urine, and Feces

Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7386 by liquid chromatography/multiple-stage mass spectroscopy method.

Time frame: Day 1 up to Day 21

Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)