Placebo Capsule Coating Formulation Scintigraphy Study (QSC201871)
Research type
Research Study
Full title
A Single-Centre, Open-Label, Four-Period Sequential Scintigraphic Imaging Study Designed to Evaluate the In Vivo Performance of Oral Capsule Coating Formulations in Healthy Subjects
IRAS ID
262993
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Applied Molecular Transport Inc.
Duration of Study in the UK
0 years, 1 months, 28 days
Research summary
Applied Molecular Transport Inc (the sponsor) are developing a new controlled release capsule. The capsule is being developed to deliver test medicines to diseased areas of the body in the lower gut without releasing any test medicine in the stomach. The sponsor are investigating three different capsule formulations (recipes) using different capsule coatings to compare the release rate of each capsule and determine where in the body the capsule releases.\n\nAs this study is developing a capsule and not a test medicine, this study will use a placebo which is a “dummy test medicine”, it contains no active medicine. The placebo in the capsule will be radiolabelled. Radiolabelled means that the placebo has a radioactive component which helps us to track where the capsule is in the body. \n\nThe study will consist of 4 periods, involving up to 12 healthy volunteers. During each period volunteers will receive 1 radiolabelled placebo capsule and will receive imaging with a gamma camera until 24 hours post dose to show where in the body the capsule is. The volunteers may receive the capsule after an overnight fast, or a high fat breakfast.\n\nThe volunteers will also receive another capsule called a SmartPill during one of the periods, 4 volunteers will receive a SmartPill during each of the 4 periods. SmartPill is a CE marked medical device which provides information about internal conditions, such as pH.\n\n
REC name
Wales REC 2
REC reference
19/WA/0117
Date of REC Opinion
11 Apr 2019
REC opinion
Favourable Opinion