Cardiovascular DiseasesPhase 1NCT05817461
An ADME Study of [14C]AZD0780 in Healthy Male Subjects
A Phase 1 study testing AZD0780 tablet, [14C]AZD0780 Solution for Infusion and [14C]AZD0780 Oral Solution in people with Cardiovascular Diseases, run by AstraZeneca at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- AZD0780 tablet, [14C]AZD0780 Solution for Infusion and [14C]AZD0780 Oral Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2023to 6 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Must be willing and able to communicate and participate in the whole study.
- Healthy male subjects aged 30 to 55 years inclusive at the time of signing informed consent.
- Must agree to adhere to the contraception requirements defined in the Clinical Protocol
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day).
Who cannot join
- History of any clinically significant disease or disorder (e.g. cardiovascular, pulmonary, GI, liver, renal, neurological, musculoskeletal ,endocrine, metabolic, malignant, psychiatric, major physical impairment, skin abnormalities and glucose metabolism abnormalities) which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of clinically significant GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0780. Hay fever is allowed unless it is active.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Evidence of current SARS-CoV-2 infection
Show all 31Show fewer
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
- Clinically significant abnormal findings in vital signs, at screening or admission, as judged by the investigator.
- Clinically significant abnormalities on 12-lead ECG, at screening or admission, as judged by the investigator.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and human immunodeficiency virus (HIV) 1 and 2 antibody
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer. Note: subjects consented and screened, but not randomised in this study or a previous Phase I study, are not excluded.
- Subjects who report to have previously received AZD0780.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
- Subjects who have been administered IMP in an ADME study in the last 12 months.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than 4 g of paracetamol/acetaminophen per day), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the two weeks prior to the first administration of IMP or longer if the medication has a long half-life. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks or 5 half-lives, whichever is longer, prior to the first administration of IMP.
- Known or suspected history of alcohol or drug abuse in the past 2 years or excessive intake of alcohol (>21 units per week [1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type]) or as judged by the investigator.
- A confirmed positive alcohol breath test at screening or admission.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening.
- A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
- Confirmed positive drugs of abuse test result at screening or admission.
- Excessive intake of caffeine-containing drinks or food (e.g. coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g. >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
- Subjects with pregnant or lactating partners
- Planned in-patient surgery, dental procedure or hospitalisation during the study.
- Involvement of any Astra Zeneca, Quotient or study site employee or their close relatives.
- Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (i.e. during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Subjects who cannot communicate reliably with the investigator.
- Vulnerable subjects, e.g. kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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 [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. In Part 2, the volunteers will receive a single oral dose of [14C]AZD0780 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- AZD0780 tablet, [14C]AZD0780 Solution for Infusion, [14C]AZD0780 Oral Solution
- Keywords
- Dyslipidaemia
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780 tabletDrug
Also called AZD0780
oral, fasted
[14C]AZD0780 Solution for InfusionDrug
Also called [14C]AZD0780
intravenous
[14C]AZD0780 Oral SolutionDrug
Also called [14C]AZD0780
oral, fasted
| Study group | Role | What they receive |
|---|---|---|
| AZD0780 | Experimental | In Part 1, one oral dose of AZD0780 and one intravenous dose of [14C]AZD0780. In Part 2, one oral dose of [14C]AZD0780 Receives: Drug: AZD0780 tablet; Drug: [14C]AZD0780 Solution for Infusion; Drug: [14C]AZD0780 Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability (F) - Part 1
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
Measured: Plasma sample collection from pre-dose to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Total body clearance calculated after a single IV administration (CL) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Volume of distribution at steady state after a single IV administration (Vss) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 1
PK of AZD0780 and [14C]AZD0780 in plasma
Measured: Plasma sample collection from pre-dose until 168 hours post-dose
Amount of AZD0780 excreted (Ae) - Part 2
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Amount of AZD0780 excreted expressed as a fraction of dose excreted (%Ae) - Part 2
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
The cumulative amount of AZD0780 exreted (CumAe) - Part 2
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Cumulative amount of AZD0780 excreted expressed as a fraction of dose excreted (Cum%Ae) - Part 2
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Renal clearance calculated using plasma AUC (CLR) - Part 2
PK of AZD0780 in urine and faeces
Measured: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Secondary outcomes (3)
Number of subjects with treatment-related adverse events - Part 1 and Part 2
To provide additional safety and tolerability information for AZD0780 by assessing the incidence of AEs
Measured: Through study duration, an average of 10 weeks
Blood:plasma concentration ratios - Part 2
Blood:plasma concentration ratios of total radioactivity
Measured: Whole blood samples and plasma samples collected from pre-dose until 240 hours post-dose
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating TR (plasma) or accounting for 10% or more of the dose in urine and faeces - Part 2
Metabolite profiling and structural identification from plasma, urine and faecal samples.
Metabolites are to be reported in a separate report after the Clinical Study Report is final.
Measured: Plasma, urine and faecal samples collected from pre-dose until 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start19 Apr 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817461
- Sponsor's protocol ID
- D7960C00004
- Status last verified
- Jun 2025
- First submitted
- 5 Apr 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05817461
- Acronym / sponsor ID
- D7960C00004
- Conditions
- Cardiovascular Diseases
- Keywords
- Dyslipidaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 [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. In Part 2, the volunteers will receive a single oral dose of [14C]AZD0780 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD0780 | Experimental | Drug: AZD0780 tablet, Drug: [14C]AZD0780 Solution for Infusion, Drug: [14C]AZD0780 Oral SolutionIn Part 1, one oral dose of AZD0780 and one intravenous dose of [14C]AZD0780. In Part 2, one oral dose of [14C]AZD0780 |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Must be willing and able to communicate and participate in the whole study.
- Healthy male subjects aged 30 to 55 years inclusive at the time of signing informed consent.
- Must agree to adhere to the contraception requirements defined in the Clinical Protocol
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Key exclusion criteria (31 listed)
- History of any clinically significant disease or disorder (e.g. cardiovascular, pulmonary, GI, liver, renal, neurological, musculoskeletal ,endocrine, metabolic, malignant, psychiatric, major physical impairment, skin abnormalities and glucose metabolism abnormalities) which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of clinically significant GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0780. Hay fever is allowed unless it is active.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0780 tabletAlso: AZD0780oral, fasted | Drug | AZD0780 |
| [14C]AZD0780 Solution for InfusionAlso: [14C]AZD0780intravenous | Drug | AZD0780 |
| [14C]AZD0780 Oral SolutionAlso: [14C]AZD0780oral, fasted | Drug | AZD0780 |
Primary outcome
Absolute bioavailability (F) - Part 1
Time frame: Plasma sample collection from pre-dose to 168 hours post-dose
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Total body clearance calculated after a single IV administration (CL) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single IV administration (Vz) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Volume of distribution at steady state after a single IV administration (Vss) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 1
Time frame: Plasma sample collection from pre-dose until 168 hours post-dose
PK of AZD0780 and [14C]AZD0780 in plasma
Amount of AZD0780 excreted (Ae) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Amount of AZD0780 excreted expressed as a fraction of dose excreted (%Ae) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
The cumulative amount of AZD0780 exreted (CumAe) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Cumulative amount of AZD0780 excreted expressed as a fraction of dose excreted (Cum%Ae) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
Mass balance of total radioactivity (TR) of [14C]AZD0780 in urine and faecal samples
Time to maximum concentration (tmax) for AZD0780 and total radioactivity - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Maximum observed concentration (Cmax) for AZD0780 and total radioactivity - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Area under the curve from time 0 to the time of last measurable concentration for AZD0780 and total radioactivity (AUC0-t) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Area under the curve from time 0 extrapolated to infinity for AZD0780 and total radioactivity (AUC0-inf) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) and total radioactivity - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Terminal elimination half-life for AZD0780 (t1/2) and total radioactivity - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD0780 (λz) and total radioactivity - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
Renal clearance calculated using plasma AUC (CLR) - Part 2
Time frame: Urine and faecal samples collected from pre-dose until 240 hours post-dose
PK of AZD0780 in urine and faeces
3 secondary outcomes
Number of subjects with treatment-related adverse events - Part 1 and Part 2
Time frame: Through study duration, an average of 10 weeks
Blood:plasma concentration ratios - Part 2
Time frame: Whole blood samples and plasma samples collected from pre-dose until 240 hours post-dose
Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating TR (plasma) or accounting for 10% or more of the dose in urine and faeces - Part 2
Time frame: Plasma, urine and faecal samples collected from pre-dose until 240 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- D7960C00004 CSR SynopsisLink provided by the sponsor.
- Results posted on AZCT.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somasekhara Menakuru, MBBS, MS, MRCS, DPM, MFPM principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0780 tablet, [14C]AZD0780 Solution for Infusion and [14C]AZD0780 Oral Solution in people with Cardiovascular Diseases, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute bioavailability (F) - Part 1 (time frame: Plasma sample collection from pre-dose to 168 hours post-dose). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.