Study to Determine the ADME of [14C]E7386 in Healthy Male Subjects
Research type
Research Study
Full title
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
IRAS ID
1005911
Contact name
Marta Díaz
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2022-000954-27
Research summary
The study drug (E7386) is currently being developed as a potential cancer treatment. Participants will participate in either Part 1 or Part 2 of the study. In both parts, participants will be screened to assess their eligibility within 28 days prior to dose administration.\nPart 1\nParticipants will be admitted to the clinic on Day-1 and will be dosed on Day 1 with a single oral 40mg dose of E7386 followed by an intravenous (into the vein) infusion containing a microdose (very small dose) solution of radiolabelled [14C]-E7386 (100μg) starting approximately 25 minutes after the oral dose and administered over 5 minutes. Participants will remain in the clinic for 96 hours post oral dose and will be released on Day 5 after End of Study Visit assessments are completed. Part 1 of the study will be run to compare the amount of study drug available to the body from an oral dose in comparison to an intravenous dose.\nPart 2\nParticipants will be admitted to the clinic on Day-1 and be dosed on Day 1 with a single 40mg oral dose of radiolabelled [14C]-E7386. Participants will remain in the clinic for a minimum of 7 days and a maximum of 21 days. Participants will be released as soon as both of the following conditions are met: (1) >90% of the administered radioactivity has been recovered, and (2) <1% of the administered radioactive dose is recovered in 2 consecutive 24-hour samples each of urine and faeces. If these release criteria are not met by Day 21, the Participant will be released from the clinic and may be required to return once weekly for 24-hour confinement to conduct 24-hour urine and faeces collections until the second release criterion is met (up to 4 weekly visits on Days 28, 35, 42, and 49). Part 2 of the study will be run to determine how the study is handled by the body, how it is removed from the body (excreted) and to determine breakdown products of the study drug (metabolites).\nThe total study duration is up to 33 days in Part 1 and 77 days in Part 2.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0105
Date of REC Opinion
15 Sep 2022
REC opinion
Further Information Favourable Opinion