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Completed
NCT07308236
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
Conditions: Healthy Volunteers
Sex: Male
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 10
Sponsor: Eisai Inc.
Location: Fortrea Clinical Research Unit Inc. Madison Wisconsin
Summary
The primary purpose of this study is to determine the metabolism and excretion of \[14C\]E2086 in healthy male participants.
Eligibility Criteria
Inclusion Criteria:
1. Non-smoking and non-vaping, healthy male, age greater than or equal to (\>=) 18 years and less than or equal to (\=18 and less than (\140 millimeter of mercury (mmHg) or diastolic blood pressure \>90 mmHg at Screening or Baseline
11. Heart rate \100 beats/min at Screening or Baseline
12. Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS).
13. Any lifetime history of psychiatric disease (including, but not limited to, depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, and anxiety disorders \[if ever treated with medication\]).
14. Known history of clinically significant drug allergy at Screening or Baseline
15. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline.
16. Known to be human immunodeficiency virus (HIV) positive at Screening
17. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or alcohol test at Screening or Baseline.
18. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
19. Use of illegal recreational drugs and marijuana
20. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing.
Source: ClinicalTrials.gov (NCT07308236). StuddyBuddy aggregates publicly available trial information.