Phase 1 trial (QSC202600)
Research type
Research Study
Full title
An Open-Label, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-ATH434 in Healthy Male Subjects
IRAS ID
1005308
Contact name
David Stamler
Contact email
Sponsor organisation
Alterity Therapeutics Limited
Eudract number
2022-000516-66
ISRCTN Number
ISRCTN10603388
Research summary
Research Summary:\nThe Sponsor is developing the test medicine, ATH434, for the potential treatment of Atypical Parkinsonism such as Multiple System Atrophy. The symptoms of Parkinsonism are tremors, slowness of movement, rigidity and problems with balance causing instability when standing.\n\nThis single period healthy volunteer study will try to look at how the test medicine is taken up, broken down and removed by the body when given orally as a capsule or tablet. To help investigate how this happens, the test medicine will be radiolabelled (the test medicine has a radioactive component, in this case Carbon-14 which is a type of naturally occurring radioactivity). The pharmacokinetics (what the body does to the drug), safety and tolerability of this test medicine will also be studied.\n\nThis phase 1 study will take place at one non-NHS site enrolling up to 6 male volunteers aged 30 - 65 years.\n\nVolunteers will receive an oral dose of the test medicine (tablet) in the fed state, 75 mg twice daily on Day 1 to 7. On Day 8, volunteers will take a single oral dose of the radiolabelled test medicine (capsule) 75 mg (not more than 4.3 MBq), in the fed state.\n\nVolunteers will be admitted to the clinic the evening before the day of dosing (Day 1). Volunteers will be discharged on Day 15, however their stay may be extended to Day 17. Volunteers will receive a follow up phone call 3-7 days post-discharge.\n\nVolunteer’s blood and urine and faeces will be taken throughout the study for analysis of the test medicine and for their safety. \n\nVolunteers are expected to be involved in this study for approximately 8 weeks from screening to the follow up call.\n
REC name
London - Westminster Research Ethics Committee
REC reference
22/FT/0096
Date of REC Opinion
30 Aug 2022
REC opinion
Further Information Favourable Opinion