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

NCT ID: NCT04493255

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2020-10-21

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

E7090

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

Group Type: EXPERIMENTAL

[14C]E7090

Intervention Type: DRUG

\[14C\]E7090, oral capsule.

Interventions

[14C]E7090

\[14C\]E7090, oral capsule.

Intervention Type: DRUG

Other Intervention Names

E7090

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 Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

2019-004957-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7090-E044-002

Identifier Type: -

Identifier Source: org_study_id