A Phase 1 interventional study of AZD4144 in Hepatic Impairment, sponsored by AstraZeneca. Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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.
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.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy Matched Control Participants Only (Group 4):
Hepatically-Impaired Participants Only (Groups 1, 2, and 3):
All Groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with mild hepatic impairment (CP Class A, score of 5 or 6)
Drug: AZD4144
Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
Drug: AZD4144
Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Drug: AZD4144
Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups
Drug: AZD4144
Single oral dose of AZD4144 in participants from all groups
PK parameters AUCinf
area under the concentration-time curve from zero to infinity
Time frame: Day 0 through Day 7 or 9
PK parameter AUClast
area under the concentration-time curve from zero to the last measurable concentration
Time frame: Day 0 through Day 7 or 9
PK parameters AUC(0-144)
area under the curve from time zero to time 144hours post dose
Time frame: Day 0 through Day 7
PK parameter Cmax
maximum observed plasma concentration
Time frame: Day 0 through Day 7 or 9
PK parameters tmax
time to reach maximum observed plasma concentration
Time frame: Day 0 through Day 7 or 9
PK Parameters t1/2λz
half-life associated with terminal slope (λz)
Time frame: Day 0 through Day 7 or 9
PK Parameters CL/F
apparent total body clearance of drug from plasma after extravascular administration
Time frame: Day 0 through Day 7 or 9
PK Parameters Vz/F
apparent volume of distribution during the terminal phase after extravascular administration.
Time frame: Day 0 through Day 7 or 9
PK Parameters CLNR/F
non-renal clearance of drug from plasma
Time frame: Day 0 through Day 7 or 9
PK parameters CLR from urine concentrations
renal clearance from urine concentration
Time frame: Day 0 through Day 3
PK parameters Ae determined from urine concentration
amount of unchanged drug excreted into the urine
Time frame: Day 0 through Day 3
PK parameters fe determined from urine concentration
Percentage of unchanged drug excreted into the urine
Time frame: Day 0 through Day 3
PK Parameters tlast
time of last quantifiable concentration
Time frame: Day 0 through Day 7 or 9
PK Parameters λz
terminal elimination rate constant
Time frame: 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
Time frame: Day 0 through Day 1
PK Parameters AUC(0-72)
area under the plasma concentration-time curve from time 0 to 72 hours postdose
Time frame: Day 0 through Day 3
Start is estimated for Aug 2026; primary completion for May 2027, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berzanoflast