Clinical trial NCT04493255: A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
Official title: An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Participants
Phase 1
Pharmacokinetics
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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 Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090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

Primary outcomes:
measure: feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine
timeFrame: Up to Day 57
measure: Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours
timeFrame: Up to Day 57
measure: fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces
timeFrame: Up to Day 57
measure: Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours
timeFrame: Up to Day 57
measure: feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)
timeFrame: Up to Day 57
measure: Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours
timeFrame: Up to Day 57
measure: Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites
timeFrame: Day 1: 0-672 hours post-dose
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites
timeFrame: Day 1: 0-672 hours post-dose
measure: AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites
timeFrame: Day 1: 0-24 hours post-dose
measure: 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
timeFrame: Day 1: 0-672 hours post-dose
measure: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites
timeFrame: Day 1: 0-672 hours post-dose
measure: T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites
timeFrame: Day 1: 0-672 hours post-dose
measure: CL/F: Apparent Total Body Clearance for E7090
timeFrame: Day 1: 0-672 hours post-dose
measure: Vd/F: Apparent Volume of Distribution for E7090
timeFrame: Day 1: 0-672 hours post-dose
measure: MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights
timeFrame: Day 1: 0-672 hours post-dose
Secondary outcomes:
measure: Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces
timeFrame: Up to Day 57
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values
timeFrame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
timeFrame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Day 29
measure: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations
timeFrame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
timeFrame: Baseline up to Day 29
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit
Study officials:
References: