ADME and PK Study of AZD4831 in Healthy Males (QSC202884)
Research type
Research Study
Full title
A Phase I, Open-Label, Single-Period Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification after Oral Administration of [14C]AZD4831 in Healthy Male Subjects
IRAS ID
281213
Contact name
Lindsay Sanford
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-000935-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 23 days
Research summary
The Sponsor is developing the test medicine, AZD4831, for the potential treatment of cardiovascular disease (CVD). CVD is a general term to describe a range of conditions that affect the heart and blood vessels, examples of CVD include angina (chest pain caused by restricted blood flow to heart muscle) and heart failure (where the heart is unable to pump blood around the body properly). AZD4831 is an inhibitor of a protein that has a role in the formation of fatty deposits in arteries (blood vessels that take blood to the body). It is hoped that by inhibiting this action, AZD4831 will help with the management of CVD.
The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body. The study will try to assess how much radioactivity can be recovered from the urine and faeces (mass balance recovery) after a single oral dose of [14C]AZD4831. It will also look to identify the breakdown products (metabolites) of the parent drug. It will additionally determine the rate and route of elimination of [14C]AZD4831, along with the level of test medicine in the blood. The safety and tolerability of the test medicine will be assessed. The dose of radiation administered is very low, therefore the risk associated with this is very small.
The study will consist of a single study period involving up to six healthy male volunteers. Up to six male volunteers will receive a dose of 10 mg of the radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 336 hours post-dose (Day 15). A follow-up visit will take place seven to ten days after discharge for safety assessments.
REC name
HSC REC B
REC reference
20/NI/0059
Date of REC Opinion
15 May 2020
REC opinion
Favourable Opinion