Clinical trial NCT03444818: A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants
Official title: A Phase I, Open-label, Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Participants
Keywords: E6007
Pharmacokinetics
Radioactivity
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum concentration (Cmax) of E6007 derived from whole blood
timeFrame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
measure: Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007
timeFrame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
measure: Total radioactivity derived from whole blood
timeFrame: Up to 11 days
measure: Total radioactivity in urine
timeFrame: Up to 11 days
measure: Total radioactivity in feces
timeFrame: Up to 11 days
Secondary outcomes:
measure: Number of participants with any serious adverse event
timeFrame: Up to 11 days
measure: Number of participants with any non-serious adverse event
timeFrame: Up to 11 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd.
state: West Yorkshire
Study officials:
References: