Phase 1 Study (QSC206403)
Research type
Research Study
Full title
A Phase 1, Single-Centre, Open-Label, 1-Part Study Designed to Assess the Pharmacokinetic Profiles of ANAVEX3-71 and its Metabolite M8 Following Administration of Modified Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Participants
IRAS ID
1006587
Contact name
Christopher Missling
Contact email
Sponsor organisation
Anavex Germany GmbH
Eudract number
2022-003288-10
ISRCTN Number
ISRCTN45504491
Research summary
The Sponsor is developing the test medicine, ANAVEX3-71, for the potential treatment of Alzheimer’s disease and frontotemporal dementia. Dementia is the name for a group of symptoms associated with an ongoing decline of brain functioning. It can affect memory, thinking skills and other mental abilities. Alzheimer’s disease is the most common cause of dementia in the UK.\n\nThis single-part healthy volunteer study will try to assess what the body does to the test medicine (pharmacokinetics) and how the body takes up the test medicine when given in two forms, a modified release (delayed; MR) tablet versus an immediate release (IR) capsule (relative bioavailability). \n\nThis study will take place at a single non-NHS site, enrolling up to 12 male and female volunteers of non-childbearing potential aged between 18 and 55 years.\n\nVolunteers will receive a single oral dose of the test medicines on five occasions, in one of the periods the reference IR oral capsule will be given, in the other four periods the MR tablet will be given. Period five may assess the effect of food on the MR tablet. \n\nVolunteers will be discharged on Day 3 of each period and will return to the clinical unit on Day 4 and Day 5 for blood samples to measure the amount of the test medicine and its metabolite (breakdown product) in the blood. There will be a minimum washout period of seven days between each dosing. Volunteers will receive a follow-up phone call seven to nine days post-final dose. \n\nVolunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and its metabolite and for their safety. \n\nVolunteers are expected to be involved in this study for 13 weeks from screening to the follow-up call.\n\nSummary of Results\n\nHas the registry been updated to include summary results?\tNo\nIf yes - please enter the URL to summary results\tn/a\nIf no – why not?\t“A deferral to full clinical trial registration on a publicly accessible database and publication of a full research summary on the HRA research summaries database is currently in place.\nA minimal dataset is published on ISRCTN and the full study dataset will be published on ISRCTN once the deferral ends. A summary of results may not be published at this end of the deferral as this is an early phase trial in healthy volunteers, and as such, the results are commercially sensitive.“\nDid you follow your dissemination plan submitted in the IRAS application form (Q A51)?\tYes\nIf yes, describe or provide URLs to disseminated materials\tThe clinical trial report has been distributed to the regulatory authorities, in line with the dissemination plan. As this is a Phase I healthy volunteer study whose results are commercially sensitive, no further publications or presentations are currently planned.\nIf pending, date when dissemination is expected\tn/a\nIf no, explain why you didn’t follow it\tn/a\nHave participants been informed of the results of the study?\tNo\nIf yes, describe and/or provide URLs to materials shared and how they were shared\tn/a\nIf pending, date when feedback is expected\tn/a\nIf no, explain why they haven’t\tThe findings of this Phase I trial are confidential owing to commercial sensitivity. Therefore, it is not appropriate to share the results of this study with volunteers at this time.\nHave you enabled sharing of study data with others?\tNo\nIf yes, describe or provide URLs to how it has been shared\tn/a\nIf no, explain why sharing hasn’t been enabled\tThe findings of this Phase I trial have been shared with the Sponsor only. As these findings are confidential owing to commercial sensitivity, it is not appropriate to share the results of this study with other researchers at this time.\nHave you enabled sharing of tissue samples and associated data with others?\tNo\nIf yes, describe or provide a URL\tn/a\nIf no, explain why\tTissue samples have been stored for future research by the Sponsor for development of this test medicine only. Volunteers have not provided consent for their samples or associated data to be shared with any other organisations.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0006
Date of REC Opinion
24 Jan 2023
REC opinion
Favourable Opinion