P-Petadeferitrin-AME-01

Study Details

This study involves 11-night residential stay with one follow up call.

Detailed Study Dates

Group B1
Check in: 29 Oct 2025 Check out: 09 Nov 2025
Follow up call: 12 Nov 2025

Group B2
Check in: 6 Nov 2025 Check out: 17 Nov 2025
Follow up call: 20 Nov 2025

Additional Details

This study is available to males and females participants with transfusion-dependent iron overload. The study is assessing safety and tolerability and also how much Petadeferitrin and its breakdown products get into the bloodstream, urine and stool. 

The study drug known as Petadeferitrin which is being developed for the treatment of Transfusion Dependent Iron Overload. 

Petadeferitrin is a new Iron Chelator which is designed to bind to excess iron and help to remove it from the body. There are 3 iron chelators approved for use in patients but it is hoped that Petadeferitrin will have fewer side effects and will be easier for patients to use.

Petadeferitrin will be given as a single oral (by mouth) dose of 6 capsules on one day only. 

The Petadeferitrin will contain carbon-14 (a radioactive form of carbon) to allow the Petadeferitrin and its breakdown products to be measured in the blood, urine and stool. The reason for this is to allow different parts of the Study Drug to be traced after it has been broken down by the body. The effective radiation dose for each participant from the radiolabelled Study Drug has been calculated to be 0.1 mSv. This is equivalent to approximately 2 weeks of average natural background radiation in the UK.