* ADME study of [14C]-ANG-3777 in Healthy Male Volunteers (QSC205137)
Research type
Research Study
Full title
An Open-Label, Single-Dose Study to Assess the Mass Balance Recovery, Metabolism and Excretion of [14C]-ANG-3777 in Healthy Male Subjects
IRAS ID
294377
Contact name
Terri Alvarez-Diez
Contact email
Sponsor organisation
Angion Biomedica Corp
Eudract number
2021-000396-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 27 days
Research summary
The Sponsor is developing the test medicine, ANG-3777, for the potential treatment of acute kidney injury (AKI) in high risk patients undergoing cardiac surgery, for the treatment of Delayed Graft function in kidney transplant recipients and as a therapy for patients with acute lung injury (ALI) from various causes including COVID-19. This study plans to explore the pharmacokinetics of ANG-3777 (what the body does to the drug) and identify how it is broken down and removed by the body when given as an injection into a vein (intravenous). To help investigate how this happens, the test medicine will be radiolabelled with a small amount of radioactivity. Radiolabelled means that the test medicine has a radioactive component (carbon-14) which allows tracking of the test medicine in the body. The study will consist of a single study period involving up to 6 healthy male volunteers. Volunteers will be admitted to the clinic on Day -1 and following an overnight fast of at least 8 hours, will receive a single intravenous administration of the test medicine as a 30-minute infusion on Day 1. Volunteers will remain in the clinical unit up to Day 8, however if the relevant radioactivity recovery criteria has not been met by Day 8, volunteers stay may be extended until Day 12 at maximum. Samples of blood, faeces and urine will be collected at pre-defined times. If the criteria are still not met at Day 12, or if a longer stay not considered appropriate or necessary, then home collections of urine and/or faeces may be required
REC name
London - London Bridge Research Ethics Committee
REC reference
21/FT/0035
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion