ADME study of [14C]AZD5718 in healthy male subjects (QSC200694)
Research type
Research Study
Full title
A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion following a Single Oral Dose of [14C]AZD5718 in Healthy Male Volunteers
IRAS ID
259075
Contact name
Nigel Fox
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-000073-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease.
Coronary artery disease (CAD) is a cardiovascular disease that is caused by the build-up of fatty substances in the coronary arteries (blood vessels that supply blood to the heart). This build-up of fatty substance can cause the blood supply to the heart to be reduced (leading to angina which causes chest pain) or become blocked (leading to a heart attack). There are current treatments for CAD but patients can still remain at risk of developing the symptoms of heart attack and angina. AstraZeneca are developing this test medicine as it acts on the body in a different way to the current treatments and may hopefully reduce the risk of these symptoms.
The study will try to identify how the test medicine, AZD5718, is absorbed, distributed, metabolised (broken down) and eliminated (removed) from the body. The metabolites (breakdown products) of the test medicine will also be investigated to identify their structure.
The study is an open-label, single dose study involving 6 healthy male subjects. The volunteers will receive a single dose of 200 mg radiolabelled AZD5718 (14C-AZD5718) containing not more than 9.9 MBq of radiocarbon, in the form of a suspension (a powder mixed with liquid to drink). 'Radiolabelled' means that the test medicine has a radioactive component which enables researchers to track where the test medicine is in the body.
Volunteers will attend the clinic for 9 days (Day -1 to Day 8) to receive a single dose of the test medicine. It is planned that the volunteers will be discharged as a group once all volunteers have reached the discharge criteria. This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the discharge criteria are not met by volunteers by Day 8, the individual volunteers who have not met the criteria will remain in the clinical unit for a further 48 h (until Day 10).
A follow-up call will take place 7 to 10 days after discharge to ensure the ongoing wellbeing of volunteers.REC name
HSC REC B
REC reference
19/NI/0046
Date of REC Opinion
16 Apr 2019
REC opinion
Further Information Favourable Opinion