Phase I Mass Balance and ADME Study of [14C]AZD0780 (QSC206208)
Research type
Research Study
Full title
An Open-Label, Two-Part Sequential Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD0780 and the Absolute Bioavailability of AZD0780 in Healthy Male Subjects
IRAS ID
1007154
Contact name
Sally Walsh
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing a new test medicine, AZD0780, with the aim to lower low-density lipoprotein cholesterol (LDL-C, fatty deposits) levels and cardiovascular (heart disease) risk, when given on top of standard care. High levels of LDL-C can build up on the walls of blood vessels, forming plaques which can increase the risk of heart disease and stroke.
This two-part healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14; also referred as 14C) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site, enrolling up to 8 male volunteers aged between 30 and 55 years.
In Part 1, volunteers will receive a single oral dose of 60 mg AZD0780 as multiple tablets, on Day 1. The volunteers will then receive a single intravenous dose of 100 µg [14C]AZD0780, 2.25 hours after the oral dose. Volunteers will be discharged on Day 8.
Following a minimum 14 day washout period, all volunteers who participated in Part 1 of the study will be admitted to the clinical unit for Part 2. The volunteers will receive a single oral dose of 60 mg [14C]AZD0780 as an oral solution, on Day 1. Volunteers will be discharged on Day 11, however, if relevant radioactivity criteria have not been met, volunteers may need to remain at the clinical unit until Day 13. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required. Volunteers will receive a follow up phone call between Day 18 and 21.
Volunteer’s blood and urine and faeces will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for 10 weeks from screening to the follow up call.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0044
Date of REC Opinion
6 Apr 2023
REC opinion
Further Information Favourable Opinion