Study to Evaluate PK of Acoramidis Modified Release Tablet (QSC204480)
Research type
Research Study
Full title
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis (AG10) Modified Release Tablet Formulations in Healthy Subjects
IRAS ID
291269
Contact name
Mark McGovern
Contact email
Sponsor organisation
Eidos Therapeutics
Eudract number
2020-005284-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
Summary of Research
The sponsor, Eidos Therapeutics, is developing an investigational test medicine (Acoramidis or AG10), for the potential treatment of a disease called Transthyretin amyloidosis (ATTR). ATTR is a rare but progressive disease where normally healthy proteins which carry hormones and vitamins in the blood change shape and collect in the heart, nerves and other organs, causing damage that gets worse over time and can lead to heart attacks, organ failure, and death.The test medicine is currently being studied as a tablet to take twice daily. The study will look at developing a new formulation (recipe) of the test medicine, which releases the medicine slowly over time, reducing the number of tablets a patient would need to take in a day.
In this study we will look at the effects of different formulations of the test medicine on the body and will also look at the safety and tolerability of the test medicine. This study also has an option to investigate the effect food has on the test medicine. Volunteers will be dosed on five separate occasions: three occasions without food, followed by two further occasions either with or without food.
The study will consist of up to 6 visits consisting of a screening visit followed by up to 5 visits each involving 4 overnight stays. There will be a break of at least 7 days between each dosing day. Up to 14 healthy male and female volunteers will be enrolled for a duration of approximately 19 weeks from the screening visit until the follow-up phone call from this clinical study.
Study procedures include physical exam, breath, urine and bloods tests, heart monitoring, blood pressure, heart rate, respiratory rate and temperature. A follow up phone call will take place 7 to 10 days post final dose ensure the ongoing wellbeing of volunteers.
Summary of Results
As this is a Phase 1 study no lay summary of results has been provided for reasons of commercial sensitivity.REC name
Wales REC 2
REC reference
21/WA/0032
Date of REC Opinion
15 Feb 2021
REC opinion
Favourable Opinion