Hepatic ImpairmentPhase 1NCT06576765
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
A Phase 1 study testing AZD0780 in people with Hepatic Impairment, run by AstraZeneca at 3 sites in United States.
Trial summary
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AZD0780
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Aug 2024to 8 Nov 2024
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 85 years of age, inclusive at screening
- For participants with normal hepatic function:
- Participant must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.
- For participants with hepatic impairment:
- Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment at screening and Day -1.
- Supporting documents confirming the participant's hepatic impairment must be available
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- Participants must be stable on a concomitant medication and/or treatment regimen. Minor changes in dosage can be accepted at the discretion of the investigator.
- Male participants:
- Males must be surgically sterile or using, in conjunction with their female partner, a highly effective method of contraception for the duration of the study (from the time of study intervention administration) until 3 months after discharge to prevent pregnancy in a partner.
- Female participants of non-childbearing potential:
- Female participants must not be pregnant and must have a negative pregnancy test at screening and check-in, must not be lactating, and must not be of childbearing potential.
Who cannot join
- For participants with normal hepatic function:
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment)
- Use of any prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before study intervention, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- For participants with hepatic impairment:
- Presence of unstable medical (eg, diabetes) or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated renal, cardiovascular, or respiratory disease) or laboratory finding which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study.
- Participant has evidence of hepatorenal syndrome or creatinine clearance < 60 mL/minute as calculated using the Cockcroft-Gault equation.
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- Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds) at screening or Day -1.
- Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period.
- Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.
- Hepatic impairment due to non-liver disease (eg, right HF).
- Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
- Clinically relevant hepatic encephalopathy (Grade 2 or more) at screening or Day -1.
- Current functioning organ transplant or anticipated to receive organ transplant within 2 months of screening or Day -1.
- Has required new medication for hepatic encephalopathy within the 3 months prior to Day -1.
- Use of concurrent medication which affects creatinine clearance (eg, cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine, or quinine) within 7 days of Day -1.
- Current or previous treatment with drugs for reduction or inhibition of PCSK9 (eg, evolocumab, alirocumab, or inclisiran).
- Use of moderate/strong inhibitors or inducers of CYP3A4/5.
- Unable to refrain from potassium binders, phosphate binders (eg, aluminium hydroxide and calcium carbonate), cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention.
- Receiving or has received within 14 days of screening, medication that contains a black box warning for significant QT prolongation. A list of prohibited medications can be found in the protocol.
- Unable to refrain from lactulose within 10 hours before and 10 hours after study intervention.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Hialeah, Florida, 33014
Research Site
Orlando, Florida, 32809
Research Site
San Antonio, Texas, 78215
About this study
Official title: A Phase I, Single-Dose, Non-Randomised, Open-label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.
Read the detailed description
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 dose 1 administered orally to male and female participants (females of non-childbearing potential) with moderate hepatic impairment and mild hepatic impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal hepatic function.
Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening:
- Group 1: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9).
- Group 2: Participants with normal hepatic function demographically matched by sex, age, and body mass index (BMI) to the impaired participants.
- Group 3 (optional): Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6).
- Conditions
- Hepatic Impairment
- Being tested
- AZD0780
- Keywords
- Hepatic Impairment, Healthy participants, AZD0780, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0780Drug
Also called Dose 1
Dose 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects with Moderate Impairment will receive a single oral dose of AZD0780 under fasted conditions. Receives: Drug: AZD0780 |
| Group 2 | Experimental | Healthy participants will receive a single oral dose of AZD0780 under fasted conditions. Receives: Drug: AZD0780 |
| Group 3 (optional) | Experimental | Subjects with Mild Impairment will receive a single oral dose of AZD0780 under fasted conditions. Receives: Drug: AZD0780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast
Area under plasma concentration-time curve from time zero to the last measurable concentration
Measured: Day 1 to Day 11
AUCinf
Area under plasma concentration-time curve from zero to infinity
Measured: Day 1 to Day 11
Cmax
Maximum observed plasma concentration
Measured: Day 1 to Day 11
Secondary outcomes (11)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function
Measured: Day 1 to Day 11
Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings
To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function
Measured: Day 1 to Day 11
Number of participants with abnormal laboratory tests results
To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function
Measured: Day 1 to Day 11
Tmax
Time to reach maximum observed plasma concentration
Measured: Day 1 to Day 11
PK parameters (t1/2λz)
Terminal elimination half-life
Measured: Day 1 to Day 11
PK parameters (CL/F)
Apparent plasma clearance
Measured: Day 1 to Day 11
PK parameters (Vz/F)
Apparent volume of distribution during the terminal phase
Measured: Day 1 to Day 11
PK parameters (AUC0-96)
Area under the plasma concentration-time curve from time zero to 96 hours
Measured: Day 1 to Day 5
PK parameters (CLR)
Renal clearance of drug from plasma
Measured: Day 1 to Day 11
PK parameters (Ae)
Amount excreted in urine
Measured: Day 1 to Day 11
PK parameters (fe)
Fraction of dose excreted in urine
Measured: Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start8 Aug 2024
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Up to three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study. All subjects will receive the study intervention: * Cohort 1 will enroll 8 participants with moderate hepatic impairment * Cohort 2 will enroll 8-16 healthy participants matched by sex, age, and BMI * Cohort 3 (optional) will enroll 8 participants with mild hepatic impairment
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576765
- Sponsor's protocol ID
- D7960C00010
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Dose, Non-Randomised, Open-label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780
- ClinicalTrials.gov ID
- NCT06576765
- Acronym / sponsor ID
- D7960C00010
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, Healthy participants, AZD0780, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 29 Aug 2024 (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.
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.
Detailed description
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 dose 1 administered orally to male and female participants (females of non-childbearing potential) with moderate hepatic impairment and mild hepatic impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal hepatic function.
Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening:
- Group 1: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9).
- Group 2: Participants with normal hepatic function demographically matched by sex, age, and body mass index (BMI) to the impaired participants.
- Group 3 (optional): Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Up to three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study. All subjects will receive the study intervention: * Cohort 1 will enroll 8 participants with moderate hepatic impairment * Cohort 2 will enroll 8-16 healthy participants matched by sex, age, and BMI * Cohort 3 (optional) will enroll 8 participants with mild hepatic impairment
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AZD0780Subjects with Moderate Impairment will receive a single oral dose of AZD0780 under fasted conditions. |
| Group 2 | Experimental | Drug: AZD0780Healthy participants will receive a single oral dose of AZD0780 under fasted conditions. |
| Group 3 (optional) | Experimental | Drug: AZD0780Subjects with Mild Impairment will receive a single oral dose of AZD0780 under fasted conditions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant must be 18 to 85 years of age, inclusive at screening
- Participant must be medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.
- Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment at screening and Day -1.
- Supporting documents confirming the participant's hepatic impairment must be available
- Participants must be stable on a concomitant medication and/or treatment regimen. Minor changes in dosage can be accepted at the discretion of the investigator.
Key exclusion criteria (20 listed)
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment)
- Use of any prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before study intervention, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Presence of unstable medical (eg, diabetes) or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated renal, cardiovascular, or respiratory disease) or laboratory finding which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study.
- Participant has evidence of hepatorenal syndrome or creatinine clearance < 60 mL/minute as calculated using the Cockcroft-Gault equation.
- Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds) at screening or Day -1.
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 |
|---|---|---|
| AZD0780Also: Dose 1Dose 1 | Drug | Group 1, Group 2, Group 3 (optional) |
Primary outcome
AUClast
Time frame: Day 1 to Day 11
Area under plasma concentration-time curve from time zero to the last measurable concentration
AUCinf
Time frame: Day 1 to Day 11
Area under plasma concentration-time curve from zero to infinity
Cmax
Time frame: Day 1 to Day 11
Maximum observed plasma concentration
11 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Day 1 to Day 11
Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings
Time frame: Day 1 to Day 11
Number of participants with abnormal laboratory tests results
Time frame: Day 1 to Day 11
Tmax
Time frame: Day 1 to Day 11
PK parameters (t1/2λz)
Time frame: Day 1 to Day 11
PK parameters (CL/F)
Time frame: Day 1 to Day 11
PK parameters (Vz/F)
Time frame: Day 1 to Day 11
PK parameters (AUC0-96)
Time frame: Day 1 to Day 5
PK parameters (CLR)
Time frame: Day 1 to Day 11
PK parameters (Ae)
Time frame: Day 1 to Day 11
PK parameters (fe)
Time frame: Day 1 to Day 11
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 10 Feb 2025.
- 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 in people with Hepatic Impairment, run by AstraZeneca at 3 sites in United States.
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 11 inclusion and 20 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
AUClast (time frame: Day 1 to Day 11). The study lists 3 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 10 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.