Status:
COMPLETED
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
Lead Sponsor:
Eisai Limited
Conditions:
Healthy Volunteers
Eligibility:
MALE
35-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- Body Mass Index (BMI) of \>=18 to \<=32 kilogram per square meter (kg/m\^2) at Screening
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- History of a minimum of 1 bowel movement per day
Exclusion
- Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)
- Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090
- 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
- Participant has the following ocular disorders:
- Any previous history or current evidence of corneal disorder
- Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)
- Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)
- Participants has a known history of food allergies or significant seasonal or perennial allergy
- Participants is known to be human immunodeficiency virus positive at Screening
- Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening
- Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04493255
Start Date
September 9 2020
End Date
October 21 2020
Last Update
February 4 2021
Active Locations (1)
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1
Covance Clinical Research Unit
Leeds, United Kingdom, LS2 9LH