A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants

Eisai Limited8 enrolled

Overview

The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants. Also, to assess the safety and tolerability of a single dose of E7090 in healthy male participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

[14C]E7090DRUG

\[14C\]E7090, oral capsule.

Eligibility

Sex: MALEMin age: 35 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Non-smoking, healthy males, age greater than or equal to (\>=) 35 years and less than or equal to (\<=) 55 years old at the time of informed consent 2. Body Mass Index (BMI) of \>=18 to \<=32 kilogram per square meter (kg/m\^2) at Screening 3. Provide written informed consent 4. Willing and able to comply with all aspects of the protocol 5. History of a minimum of 1 bowel movement per day Exclusion Criteria: 1. Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline) 2. Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090 3. Participant has had exposure to significant diagnostic or therapeutic radiation (example: serial x-ray, computed tomography scan, barium meal) or has current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1 4. Participant has the following ocular disorders: 1. Any previous history or current evidence of corneal disorder 2. Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease) 5. Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1) 6. Participants has a known history of food allergies or significant seasonal or perennial allergy 7. Participants is known to be human immunodeficiency virus positive at Screening 8. Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening 9. Participant has a poor peripheral venous access, in the opinion of the investigator (or designee) 10. Participant received blood products within 2 months prior to Day -1, or donation of blood within 3 months prior to Screening, donation of plasma within 2 weeks prior to Screening, or donation of platelets from 6 weeks prior to Screening

Locations (1)

Covance Clinical Research Unit

Leeds, United Kingdom

Outcomes

Primary Outcomes

feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine

Time frame: Up to Day 57

Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours

Time frame: Up to Day 57

fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces

Time frame: Up to Day 57

Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours

Time frame: Up to Day 57

feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)

Time frame: Up to Day 57

Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours

Time frame: Up to Day 57

Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites

Time frame: Day 1: 0-672 hours post-dose

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites

Time frame: Day 1: 0-672 hours post-dose

AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites

Time frame: Day 1: 0-24 hours post-dose

AUC(0-t): Area Under the Concentration- time Curve From Time 0 to Time of Last Quantifiable Concentration for [14C]E7090, E7090 and its Metabolites

Data from ClinicalTrials.gov

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Secondary Outcomes

Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces

Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7090 by Liquid Chromatography/ multiple-stage Mass Spectroscopy method.

Time frame: Up to Day 57

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Baseline up to Day 57

Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values