Abs Bio and ADME Study of [14C]AZD9977 in Healthy Males (QSC203099)
Research type
Research Study
Full title
A Phase I, Open-label Study of Absolute Bioavailability and Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]AZD9977 in Healthy Male Subjects
IRAS ID
288264
Contact name
Rocelyn DelCarmen
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-004998-42
Duration of Study in the UK
0 years, 1 months, 16 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, AZD9977, for the potential treatment of chronic heart failure. Heart failure is when the heart is unable to pump blood around the body properly, and usually occurs when the heart becomes weak or stiff.
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 evaluate the absolute bioavailability (amount of the test medicine that enters the blood stream), along with the mass balance (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of [14C]AZD9977. It will also look to identify the breakdown products (metabolites) of the test medicine. The safety and tolerability of the test medicine will be assessed, along with pharmacokinetics (how much test medicine is taken up by the body).
The study will consist of two periods involving up to eight healthy male volunteers. In period 1, volunteers will receive a single dose of the test medicine as two capsules, followed by an intravenous infusion (solution into the vein) of the radiolabelled test medicine. Volunteers will remain resident in the clinical unit until 72-hours post-oral dose.
There will be a minimum washout period of 7 days between dosing in period 1 and period 2, after which the volunteers will return to the clinical unit for period 2. Volunteers will receive a single dose of the radiolabelled test medicine as an oral suspension (thick drink).
Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours post-dose (Day 8), with the possibility of extension until Day 10. There will be a follow-up visit 15-18 days post-final dose for safety assessments.
Summary of Results
A lay summary of results is currently not available, this will be made available and posted on trialsummaries.com within two years of the study completion date.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/1240
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion