Hepatic ImpairmentPhase 1NCT06813781
Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
A Phase 1 study testing AZD5004 in people with Hepatic Impairment, run by AstraZeneca at 5 sites in United States.
Trial summary
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AZD5004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Dec 2024to 2 Oct 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For ALL participants:
- Adults 18-80 years of age
- Weight ≥50kg and BMI between ≥18 to ≤40 kg/m2 For participants with normal hepatic function:
- Participant must be stable on a concomitant medication and/or treatment regimen for at least 2 weeks prior to screening
- For Healthy Controls:
- -Participant must be medically healthy with no significant findings on medical evaluation at screening to include but not limited to an eGFR >90 ml/min/1.73 m2
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- For participants with hepatic impairment:
- Group 1 (mild) must have an Child-Pugh score of 5 or 6, Group 2 (moderate) must have a Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to 15.
- Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening
Who cannot join
- For ALL participants:
- Poorly controlled diabetes mellitus (A1C >10% at screening).
- Unwillingness to use adequate contraception
- Uncontrolled hypertension or hypotension
- Presence of unstable systemic disease or psychologic conditions.
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG.
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- Specific For Healthy Controls:
- -Positive screening for HIV, Hepatitis B, or Hepatitis C -
- -Any clinically significant disease or disorder to include but not limited to acute or chronic liver disease
- Specific For Hepatically Impaired Participants:
- eGFR <60 ml/min/1.73 m2
- Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment to include rising LFTs, paracentesis at less than 4 week intervals, oesophageal banding within the last 3 months, or treatment for GI bleeding within the last 6 months
- Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Lake Forest, California, 92630
Research Site
Miami Lakes, Florida, 33014
Research Site
Orlando, Florida, 32809
Research Site
Rialto, California, 92377
Research Site
San Antonio, Texas, 78215
About this study
Official title: A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function.
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 AZD5004 in male and female participants with mild, moderate, or severe hepatic impairment compared with participants 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 mild hepatic impairment (Child Pugh Class A, score of 5 or 6).
Group 2: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9).
Group 3: Participants with severe hepatic impairment (Child Pugh Class C, score of 10 to 15).
Group 4: Participants with normal hepatic function matched on a group level regarding sex, age, and body weight to the impaired participants.
- Conditions
- Hepatic Impairment
- Being tested
- AZD5004
- Keywords
- Hepatic Impairment, Healthy participants, AZD5004, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5004Drug
Also called ECC5004, Dose 1
Dose 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | A single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
| Group 2 | Experimental | A single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
| Group 3 | Experimental | A single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
| Group 4 | Experimental | A single oral dose of AZD5004 under fasted conditions. Receives: Drug: AZD5004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Area under plasma concentration-time curve from zero to infinity
Measured: Day 1 to Day 6
AUClast
Area under plasma concentration-time curve from time zero to the last measurable concentration
Measured: Day 1 to Day 6
Cmax
Maximum observed plasma concentration
Measured: Day 1 to Day 6
Secondary outcomes (8)
Tmax
Time to reach maximum observed plasma concentration
Measured: Day 1 to Day 6
PK parameters (t1/2λz)
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve
Measured: Day 1 to Day 6
PK parameters CL/F
Apparent total body clearance of drug from plasma after extravascular administration
Measured: Day 1 to Day 6
PK parameters CLNR/F
Non-renal clearance of drug from plasma after oral administration
Measured: Day 1 to Day 6
PK parameter Vz/F
Apparent volume of distribution during the terminal phase after extravascular administration
Measured: Day 1 to Day 6
PK parameter CLr
Renal clearance of the drug from plasma
Measured: Day 1 to Day 6
PK parameter Ae
Cumulative amount of unchanged drug excreted into the urine
Measured: Day 1 to Day 6
fe
Fraction of the drug excreted into the urine
Measured: Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start19 Dec 2024
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
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 four groups (three hepatic impairment groups and controls with normal hepatic function) will be enrolled into this study. All participants will receive the study intervention: * Cohort 1 will enroll 8 participants with mild hepatic impairment * Cohort 2 will enroll 8 participants with moderate hepatic impairment * Cohort 3 will enroll 6-8 participants with severe hepatic impairment * Cohort 4 will enroll \~8 participants with normal hepatic function matched by sex, age, and body weight
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea Clinical Research Unit Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813781
- Sponsor's protocol ID
- D7260C00011
- Status last verified
- Oct 2025
- First submitted
- 17 Dec 2024
- Last updated
- 15 Oct 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 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
- ClinicalTrials.gov ID
- NCT06813781
- Acronym / sponsor ID
- D7260C00011
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, Healthy participants, AZD5004, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea Clinical Research Unit Inc.
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 7 Feb 2025 (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 is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function.
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 AZD5004 in male and female participants with mild, moderate, or severe hepatic impairment compared with participants 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 mild hepatic impairment (Child Pugh Class A, score of 5 or 6).
Group 2: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9).
Group 3: Participants with severe hepatic impairment (Child Pugh Class C, score of 10 to 15).
Group 4: Participants with normal hepatic function matched on a group level regarding sex, age, and body weight to the impaired participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Up to four groups (three hepatic impairment groups and controls with normal hepatic function) will be enrolled into this study. All participants will receive the study intervention: * Cohort 1 will enroll 8 participants with mild hepatic impairment * Cohort 2 will enroll 8 participants with moderate hepatic impairment * Cohort 3 will enroll 6-8 participants with severe hepatic impairment * Cohort 4 will enroll ~8 participants with normal hepatic function matched by sex, age, and body weight
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AZD5004A single oral dose of AZD5004 under fasted conditions. |
| Group 2 | Experimental | Drug: AZD5004A single oral dose of AZD5004 under fasted conditions. |
| Group 3 | Experimental | Drug: AZD5004A single oral dose of AZD5004 under fasted conditions. |
| Group 4 | Experimental | Drug: AZD5004A single oral dose of AZD5004 under fasted conditions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 18-80 years of age
- Weight ≥50kg and BMI between ≥18 to ≤40 kg/m2 For participants with normal hepatic function:
- Participant must be stable on a concomitant medication and/or treatment regimen for at least 2 weeks prior to screening
- -Participant must be medically healthy with no significant findings on medical evaluation at screening to include but not limited to an eGFR >90 ml/min/1.73 m2
- Group 1 (mild) must have an Child-Pugh score of 5 or 6, Group 2 (moderate) must have a Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to 15.
Key exclusion criteria (13 listed)
- Poorly controlled diabetes mellitus (A1C >10% at screening).
- Unwillingness to use adequate contraception
- Uncontrolled hypertension or hypotension
- Presence of unstable systemic disease or psychologic conditions.
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG.
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 |
|---|---|---|
| AZD5004Also: ECC5004, Dose 1Dose 1 | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
AUCinf
Time frame: Day 1 to Day 6
Area under plasma concentration-time curve from zero to infinity
AUClast
Time frame: Day 1 to Day 6
Area under plasma concentration-time curve from time zero to the last measurable concentration
Cmax
Time frame: Day 1 to Day 6
Maximum observed plasma concentration
8 secondary outcomes
Tmax
Time frame: Day 1 to Day 6
PK parameters (t1/2λz)
Time frame: Day 1 to Day 6
PK parameters CL/F
Time frame: Day 1 to Day 6
PK parameters CLNR/F
Time frame: Day 1 to Day 6
PK parameter Vz/F
Time frame: Day 1 to Day 6
PK parameter CLr
Time frame: Day 1 to Day 6
PK parameter Ae
Time frame: Day 1 to Day 6
fe
Time frame: Day 1 to Day 6
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 15 Oct 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.
5 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 AZD5004 in people with Hepatic Impairment, run by AstraZeneca at 5 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 9 inclusion and 13 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 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
AUCinf (time frame: Day 1 to Day 6). 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 15 Oct 2025.