Multiple Dose Pharmacokinetics of an Acoramidis (AG10) Modified Release Tablet (QSC206655)
Research type
Research Study
Full title
A Multiple Dose Study to Evaluate the Pharmacokinetics of an Acoramidis (AG10) Modified Release Tablet Formulation in Healthy Subjects
IRAS ID
1005767
Contact name
Stuart Heminway
Contact email
Sponsor organisation
Eidos Therapeutics, Inc.
ISRCTN Number
ISRCTN11628974
Research summary
The Sponsor 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. This trial will look at developing a new formulation (recipe) of the test medicine, which releases the medicine slowly over time, reducing the number of occasions a patient would need to take in a day.
In this trial we will look at the effects of a new formulation of the test medicine on the body and will also look at the safety and tolerability of the test medicine when administered once daily for 7 days. We may assess an alternative dose level, or the effect of food on the test medicine in Cohort 2 which is optional.
This trial will take place at one non-NHS site, enrolling up to 28 male and female volunteers aged between 18 and 65.
Volunteers will receive oral doses of acoramidis MR tablet 1100 mg once daily for 7 days (Days 1 to 7) in the fasted state in Cohort 1, and in the fed state or acoramidis MR tablet XXXX mg once daily for 7 days (Days 1 to 7) in the fed or fasted state in Cohort 2. Volunteers will be discharged on Day 10 and will return to the clinic on Days 11, 12 and 14 for follow-up visits. The decision whether to commence with Cohort 2/Regimen B and the dose and prandial status to be used will only be made after a complete review of all data collected from Cohort 1/Regimen A.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Each volunteer is expected to be involved in this study for approximately 10 weeks from screening to the final follow up phone call.REC name
HSC REC A
REC reference
22/NI/0106
Date of REC Opinion
1 Aug 2022
REC opinion
Further Information Favourable Opinion