* Scintigraphy and Relative Bioavailability Study of E7386 (QSC203335)
Research type
Research Study
Full title
An Open-Label, Single Centre, Randomised, Pharmacoscintigraphic Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release Tablets compared to an E7386 Immediate Release Tablet in Healthy Adult Subjects
IRAS ID
292624
Contact name
Andrew Willcox
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2020-005638-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 6 days
Research summary
The Sponsor is developing the test medicine, E7386, for the potential treatment of cancer.
In this study a new prototype tablet of E7386 will be compared to a reference immediate release (IR) tablet of E7386. In two periods, the new formulation (recipe) will be radiolabelled with indium, which when taking images with a specialized camera, allows us to track how the formulations travel down the GI tract when swallowed.
The study will try to evaluate the pharmacokinetic profile of the test medicine (how the test medicine is taken up by the body) along with the relative bioavailability (the proportion of test medicine that enters the body compared in two forms) of the IR and new tablet formulation. Safety and tolerability will also be assessed.
The study will consist of up to four periods involving up to 12 healthy male and female volunteers [of non-childbearing potential]. In periods 1 to 3, volunteers will receive a single dose of the reference tablet or the radiolabelled test medicine in a random order. When given the radiolabelled test medicine, images will be taken of the gut periodically from immediately after dosing until approximately 48 hours post-dose. A SmartPill® Capsule will be administered to in the two periods when the radiolabelled test medicine is administered. A SmartPill® Capsule is a single-use ingestible capsule that measures the pressure, pH and temperature throughout the GI tract. It will be used as a research tool to assess the performance of each of the tablets. Period 4 is optional, if utilised volunteers will receive a single dose of non-radiolabelled test medicine.
In each period, volunteers will remain on site until 48 hours after dosing, there will be a minimum washout period of 10 days between doses in periods 1-3, or 21 days between periods 3-4.
Lay summary of study results: no patients or sites were recruited to this study and thus, no data was generated
REC name
London - Riverside Research Ethics Committee
REC reference
21/FT/0025
Date of REC Opinion
5 Mar 2021
REC opinion
Favourable Opinion