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

NCT04493255 | Completed Phase 1

• 2 other identifiers: E7090-E044-0022019-004957-10
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy Participants; Phase 1; Pharmacokinetics

Outcome Measures

Primary Outcomes (15)

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

  Up to Day 57

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

  Up to Day 57

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

  Up to Day 57

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

  Up to Day 57

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

  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

  Up to Day 57

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

  Day 1: 0-672 hours post-dose

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

  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

  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

  Day 1: 0-672 hours post-dose

• AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites

  Day 1: 0-672 hours post-dose

• T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites

  Day 1: 0-672 hours post-dose

• CL/F: Apparent Total Body Clearance for E7090

  Day 1: 0-672 hours post-dose

• Vd/F: Apparent Volume of Distribution for E7090

  Day 1: 0-672 hours post-dose

• MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights

  Day 1: 0-672 hours post-dose

Secondary Outcomes (8)

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

  Up to Day 57

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

  Baseline up to Day 57

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

  Baseline up to Day 29

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values

  Baseline up to Day 29

• Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings

  Baseline up to Day 29

Study Arms (1)

E7090

EXPERIMENTAL

Participants will receive 100 microcurie (μCi) of \[14C\]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.

Drug: [14C]E7090

Interventions

[14C]E7090 DRUG

\[14C\]E7090, oral capsule.

Also known as: E7090

E7090

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Body Mass Index (BMI) of \>=18 to \<=32 kilogram per square meter (kg/m\^2) at Screening
• Provide written informed consent
• Willing and able to comply with all aspects of the protocol
• History of a minimum of 1 bowel movement per day

You may not qualify if:

• Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)
• Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090
• 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
• Participant has the following ocular disorders:
• Any previous history or current evidence of corneal disorder
• Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)
• Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)
• Participants has a known history of food allergies or significant seasonal or perennial allergy
• Participants is known to be human immunodeficiency virus positive at Screening
• Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening
• Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)
• 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

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (1)

Covance Clinical Research Unit

Leeds, LS2 9LH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 30, 2020
• Study Start: September 9, 2020
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: February 4, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)