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

E

EA Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy Male Participants

Treatments

Drug: [14C]-E6007

Study type

Interventional

Funder types

Industry

Identifiers

NCT03444818
2017-004119-38 (EudraCT Number)
E6007-CP3

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 30 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

[14C]-E6007
Experimental group
Description:
Participants will receive a single oral dose of 60 milligrams (mg) of [14C]-E6007.
Treatment:
Drug: [14C]-E6007

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems