Labcorp Clinical Research Unit
Leeds, LS11 9EH, United Kingdom
NCT Number: NCT05607537
The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg [microgram]) solution for Part 1 and to determine the pharmacokinetic (PK) and excretion of E7386 following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part 2.
Looking for future studies?
Notify Me30 year–55 year
Male
Interventional
Phase 1
Leeds, LS11 9EH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
E7386 40 mg tablet.
(14C)E7386 40 mg capsule.
(14C)E7386 administered intravenously.
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 12 hours post-dose
Time frame: Pre-dose (0 hour) up to 24 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 96 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 12 hours post-dose
Time frame: Pre-dose (0 hour) up to 24 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Pre-dose (0 hour) up to 480 hours post-dose
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day -1 (Baseline) up to Day 49
Time frame: Day 1 up to Day 21
Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7386 by liquid chromatography/multiple-stage mass spectroscopy method.
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Laboratory assessment will include hematology, clinical chemistry, and urinalysis parameters.
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Vital sign measurements will include systolic and diastolic blood pressure (BP), pulse rate, respiratory rate, body temperature.
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
Time frame: Part 1: Up to Day 5; Part 2: Up to Day 49
The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior is indicated when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation is indicated when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide.
Eisai Limited
Industry
An Open-Label, Single-Center, 2-Part, Parallel Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of [14C]E7386 in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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