A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants

NCT03444818 | Completed Phase 1

• 2 other identifiers: E6007-CP32017-004119-38
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of \[14C\]-E6007 in healthy male participants.

Conditions

Healthy Male Participants

Keywords

E6007; Pharmacokinetics; Radioactivity

Outcome Measures

Primary Outcomes (5)

• Maximum concentration (Cmax) of E6007 derived from whole blood

  Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose

• Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007

  Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose

• Total radioactivity derived from whole blood

  Up to 11 days

• Total radioactivity in urine

  Up to 11 days

• Total radioactivity in feces

  Up to 11 days

Secondary Outcomes (2)

• Number of participants with any serious adverse event

  Up to 11 days

• Number of participants with any non-serious adverse event

  Up to 11 days

Study Arms (1)

[14C]-E6007

EXPERIMENTAL

Participants will receive a single oral dose of 60 milligrams (mg) of \[14C\]-E6007.

Drug: [14C]-E6007

Interventions

[14C]-E6007 DRUG

Oral administration

[14C]-E6007

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 55 years of age
• Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m\^2), and a total body weight between 50 and 100 kilograms (kg)
• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations
• Males will agree to use contraception
• Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, and hernia repair will be allowed)
• Significant history or clinical manifestation of hemorrhoids
• History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
• Positive hepatitis panel and/or positive human immunodeficiency virus test
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in
• Use or intend to use any prescription medications/products within 14 days prior to Check-in
• Participants in receipt of a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study and for 14 days after the dose of study drug
• Use of tobacco or nicotine containing products within 3 months prior to Check-in
• Receipt of blood products within 2 months prior to Check-in
• Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening
• Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
• Participants who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to Check-in

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd.

Leeds, West Yorkshire, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: April 17, 2018
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-02

Locations

GB (1)