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

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493255
• Other study ID #: E7090-E044-002
• Secondary ID: 2019-004957-10
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2020
• Est. completion date: October 21, 2020

Study information

• Verified date: July 2020
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 21, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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 Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]E7090
[14C]E7090, oral capsule.

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine		Up to Day 57
Primary	Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours		Up to Day 57
Primary	fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces		Up to Day 57
Primary	Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours		Up to Day 57
Primary	feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)		Up to Day 57
Primary	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
Primary	Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites		Day 1: 0-672 hours post-dose
Primary	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites		Day 1: 0-672 hours post-dose
Primary	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
Primary	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
Primary	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
Primary	T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites		Day 1: 0-672 hours post-dose
Primary	CL/F: Apparent Total Body Clearance for E7090		Day 1: 0-672 hours post-dose
Primary	Vd/F: Apparent Volume of Distribution for E7090		Day 1: 0-672 hours post-dose
Primary	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	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.	Up to Day 57
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)		Baseline up to Day 57
Secondary	Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values		Baseline up to Day 29
Secondary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values		Baseline up to Day 29
Secondary	Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings		Baseline up to Day 29
Secondary	Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality will be reported for this outcome measure.	Baseline up to Day 29
Secondary	Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations	Ophthalmic examinations includes visual acuity, funduscopy, optical coherence tomography, and slit-lamp examination.	Baseline up to Day 29
Secondary	Number of Participants With Clinically Significant Change From Baseline in Physical Examinations		Baseline up to Day 29