Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817461
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2023-04-05
Brief Title:
An ADME Study of 14CAZD0780 in Healthy Male Subjects
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Open-Label Two-Part Sequential Study Designed to Assess the Mass Balance Recovery Absorption Metabolism Excretion of 14CAZD0780 and the Absolute Bioavailability of AZD0780 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Detailed Description:
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 AZD0780 on Day 1 The volunteers will then receive a single intravenous dose of 14CAZD0780 225 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 In Part 2 the volunteers will receive a single oral dose of 14CAZD0780 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 andor faeces may be required
Volunteers will receive a follow up phone call between Day 18 and 21
Volunteers 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
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 AZD0780 on Day 1 The volunteers will then receive a single intravenous dose of 14CAZD0780 225 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 In Part 2 the volunteers will receive a single oral dose of 14CAZD0780 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 andor faeces may be required
Volunteers will receive a follow up phone call between Day 18 and 21
Volunteers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None