Hepatic ImpairmentPhase 1NCT07783308
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144
A Phase 1 study testing AZD4144 in people with Hepatic Impairment, run by AstraZeneca at 4 sites in United States.
Trial summary
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls 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?
- AZD4144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Aug 2026to 28 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy Matched Control Participants Only (Group 4):
- 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.
- Hepatically-Impaired Participants Only (Groups 1, 2, and 3):
- Must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (e.g., no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening, as determined by the investigator at screening and Day -1).
- Must be classified by the investigator as CP Class A (Group 1), CP Class B (Group 2), or CP Class C (Group 3) at screening.
- Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication[s] or a change in the dosage or frequency of the concomitant medication[s] within at least 2 weeks prior to screening).
Show all 9Show fewer
- All Groups:
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 45 kg/m2, inclusive.
- All Females of Childbearing Potential (FOCBP) must have a negative pregnancy test at screening and Day -1.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Have Type 1 diabetes mellitus or T2DM (Group 4)
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- History of long QT syndrome or prolonged QTcF.
- Presence of unstable medical or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (e.g., currently unstable or uncompensated renal, cardiovascular, or respiratory disease).
- Evidence of renal impairment at screening
Show all 12Show fewer
- Current liver transplant or anticipated to receive liver transplant within 2 months of screening or Day -1 (Group 1, 2 and 3).
- Use of any of the prescription and non-prescription prohibited medications.
- Concomitant immunosuppressive, steroid treatment.
- Live or attenuated vaccines within 3 months prior to study intervention or live vaccinations planned during the trial.
- History of severe allergy/hypersensitivity of AZD4144 or any of the excipients of the product.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to study intervention in this study or, if known, 5 half-lives from last dose in the previous study to study intervention in this study, whichever is longest.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States4 sites
Research Site
Austin, Texas, 78757
Research Site
Mesa, Arizona, 85210
Research Site
Miami Lakes, Florida, 33014
Research Site
Orlando, Florida, 32809
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 AZD4144
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.
Read the detailed description
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.
Approximately 60 participants are planned to be screened to achieve up to 30 evaluable participants. For each of the 3 hepatic impairment groups, 6 participants are planned to complete the study. Initially, 6 participants with normal hepatic function will be recruited, matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment. Additional participants with normal hepatic function, up to a total of 12, may be included if needed to meet the matching criteria.
- Conditions
- Hepatic Impairment
- Being tested
- AZD4144
- Keywords
- Hepatic Impairment, Mild hepatic impairment, Moderate hepatic impairment, Severe hepatic impairment, Matched Healthy normal, AZD4144
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4144Drug
Single oral dose of AZD4144 in participants from all groups
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants with mild hepatic impairment (CP Class A, score of 5 or 6) Receives: Drug: AZD4144 |
| Group 2 | Experimental | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Receives: Drug: AZD4144 |
| Group 3 | Experimental | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Receives: Drug: AZD4144 |
| Group 4 | Experimental | Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups Receives: Drug: AZD4144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters AUCinf
area under the concentration-time curve from zero to infinity
Measured: Day 0 through Day 7 or 9
PK parameter AUClast
area under the concentration-time curve from zero to the last measurable concentration
Measured: Day 0 through Day 7 or 9
PK parameters AUC(0-144)
area under the curve from time zero to time 144hours post dose
Measured: Day 0 through Day 7
PK parameter Cmax
maximum observed plasma concentration
Measured: Day 0 through Day 7 or 9
Secondary outcomes (12)
PK parameters tmax
time to reach maximum observed plasma concentration
Measured: Day 0 through Day 7 or 9
PK Parameters t1/2λz
half-life associated with terminal slope (λz)
Measured: Day 0 through Day 7 or 9
PK Parameters CL/F
apparent total body clearance of drug from plasma after extravascular administration
Measured: Day 0 through Day 7 or 9
PK Parameters Vz/F
apparent volume of distribution during the terminal phase after extravascular administration.
Measured: Day 0 through Day 7 or 9
PK Parameters CLNR/F
non-renal clearance of drug from plasma
Measured: Day 0 through Day 7 or 9
PK parameters CLR from urine concentrations
renal clearance from urine concentration
Measured: Day 0 through Day 3
PK parameters Ae determined from urine concentration
amount of unchanged drug excreted into the urine
Measured: Day 0 through Day 3
PK parameters fe determined from urine concentration
Percentage of unchanged drug excreted into the urine
Measured: Day 0 through Day 3
PK Parameters tlast
time of last quantifiable concentration
Measured: Day 0 through Day 7 or 9
PK Parameters λz
terminal elimination rate constant
Measured: Day 0 through Day 7 or 9
PK Parameters AUC(0-24)
area under the plasma concentration-time curve from time 0 to 24 hours postdose
Measured: Day 0 through Day 1
PK Parameters AUC(0-72)
area under the plasma concentration-time curve from time 0 to 72 hours postdose
Measured: Day 0 through Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion28 May 2027 (estimated)
- Study completion28 May 2027 (estimated)
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
- Participants will be enrolled into the following groups based on their Child-Pugh classification score as determined by a local laboratory 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 BMI to the impaired groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783308
- Sponsor's protocol ID
- D9441C00007
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. 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 AZD4144
- ClinicalTrials.gov ID
- NCT07783308
- Acronym / sponsor ID
- D9441C00007
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, Mild hepatic impairment, Moderate hepatic impairment, Severe hepatic impairment, Matched Healthy normal, AZD4144
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 28 May 2027 (estimated)
- First posted
- 24 Aug 2026 (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 Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.
Detailed description
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched controls with normal hepatic function.
Approximately 60 participants are planned to be screened to achieve up to 30 evaluable participants. For each of the 3 hepatic impairment groups, 6 participants are planned to complete the study. Initially, 6 participants with normal hepatic function will be recruited, matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment. Additional participants with normal hepatic function, up to a total of 12, may be included if needed to meet the matching criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled into the following groups based on their Child-Pugh classification score as determined by a local laboratory 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 BMI to the impaired groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AZD4144Participants with mild hepatic impairment (CP Class A, score of 5 or 6) |
| Group 2 | Experimental | Drug: AZD4144Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). |
| Group 3 | Experimental | Drug: AZD4144Participants with severe hepatic impairment (CP Class C, score of 10 to 15). |
| Group 4 | Experimental | Drug: AZD4144Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (e.g., no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening, as determined by the investigator at screening and Day -1).
- Must be classified by the investigator as CP Class A (Group 1), CP Class B (Group 2), or CP Class C (Group 3) at screening.
- Participant must be stable on a concomitant medication and/or treatment regimen (defined as not starting a new treatment/medication[s] or a change in the dosage or frequency of the concomitant medication[s] within at least 2 weeks prior to screening).
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 45 kg/m2, inclusive.
Key exclusion criteria (12 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Have Type 1 diabetes mellitus or T2DM (Group 4)
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- History of long QT syndrome or prolonged QTcF.
- Presence of unstable medical or psychological conditions, or any evidence of additional severe or uncontrolled systemic disease (e.g., currently unstable or uncompensated renal, cardiovascular, or respiratory disease).
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 |
|---|---|---|
| AZD4144Single oral dose of AZD4144 in participants from all groups | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
PK parameters AUCinf
Time frame: Day 0 through Day 7 or 9
area under the concentration-time curve from zero to infinity
PK parameter AUClast
Time frame: Day 0 through Day 7 or 9
area under the concentration-time curve from zero to the last measurable concentration
PK parameters AUC(0-144)
Time frame: Day 0 through Day 7
area under the curve from time zero to time 144hours post dose
PK parameter Cmax
Time frame: Day 0 through Day 7 or 9
maximum observed plasma concentration
12 secondary outcomes
PK parameters tmax
Time frame: Day 0 through Day 7 or 9
PK Parameters t1/2λz
Time frame: Day 0 through Day 7 or 9
PK Parameters CL/F
Time frame: Day 0 through Day 7 or 9
PK Parameters Vz/F
Time frame: Day 0 through Day 7 or 9
PK Parameters CLNR/F
Time frame: Day 0 through Day 7 or 9
PK parameters CLR from urine concentrations
Time frame: Day 0 through Day 3
PK parameters Ae determined from urine concentration
Time frame: Day 0 through Day 3
PK parameters fe determined from urine concentration
Time frame: Day 0 through Day 3
PK Parameters tlast
Time frame: Day 0 through Day 7 or 9
PK Parameters λz
Time frame: Day 0 through Day 7 or 9
PK Parameters AUC(0-24)
Time frame: Day 0 through Day 1
PK Parameters AUC(0-72)
Time frame: Day 0 through Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
AstraZeneca Clinical Study Information Center contact
4 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 AZD4144 in people with Hepatic Impairment, run by AstraZeneca at 4 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 12 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters AUCinf (time frame: Day 0 through Day 7 or 9). The study lists 4 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 24 Aug 2026.