Hepatic ImpairmentPhase 1NCT05919069
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693
A Phase 1 study testing AZD2693 in people with Hepatic Impairment, run by AstraZeneca at 3 sites in United States.
Trial summary
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AZD2693
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2023to 16 Sep 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Hepatic:
- Participant with a diagnosis of chronic and stable hepatic impairment
- For Healthy:
- Participant with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECGs,
- All participants:
- Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening
Who cannot join
- Participant with impaired hepatic function has eGFR < 60 mL/minute/1.73 m2 and participant with normal hepatic function has eGFR < 90 mL/minute/1.73 m2
- Positive test for HIV at screening
- History or presence of clinically significant thyroid disease
- History or presence of clinically significant or unstable medical or psychiatric condition
- History of any major surgical procedure within 30 days prior to study intervention
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Miami Lakes, Florida, 33014
Research Site
Orlando, Florida, 32808
Research Site
Rialto, California, 92377
About this study
Official title: A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of AZD2693.
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
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 AZD2693 administered as an subcutaneous injection in male and female participants with mild, moderate, or severe hepatic impairment compared with male and female participants with normal hepatic function (as control). Eight participants with mild impairment (CP Class A); 8 participants with moderate impairment (CP Class B); 8 participants with severe impairment (CP Class C); and 8 to12 participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired participants are planned for study intervention with the goal of having at least 6 evaluable participants within each group. Study participants who self-withdraw after study intervention may be replaced to ensure that at least 6 participants per group are evaluable and complete the study per protocol. An evaluable participant is defined as having adequate plasma PK profile to meet the primary study objective. Child-Pugh scoring, detailed in Table 2, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6).
Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Group 4: Participants with normal hepatic function.
Study Arms and Duration:
- Planned screening duration per participant: up to 4 weeks.
- Planned study duration (screening to follow-up) per participant: up to 16 weeks.
- Conditions
- Hepatic Impairment
- Being tested
- AZD2693
- Keywords
- Mild, Moderate, Severe, Healthy Matches
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2693Drug
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants with mild hepatic impairment (CP Class A, score of 5 or 6) Receives: Drug: AZD2693 |
| Group 2 | Experimental | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9) Receives: Drug: AZD2693 |
| Group 3 | Experimental | Participants with severe hepatic impairment (CP Class C, score of 10 to 15) Receives: Drug: AZD2693 |
| Group 4 | Experimental | Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups Receives: Drug: AZD2693 |
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 (AUC) from zero to infinity (AUCinf)
Measured: 85 days
PK parameters AUClast
area under the concentration-time curve from time zero to last time of quantifiable concentration
Measured: 85 days
PK parameters Cmax
maximum observed plasma concentration
Measured: 85 days
Secondary outcomes (8)
PK parameters tmax
tmax: time to maximum observed plasma concentration
Measured: 85 days
PK parameters tlast
tlast: time of the last measurable concentration
Measured: 85 days
PK parameters t1/2λz
apparent terminal elimination half-life
Measured: 85 days
PK parameters CL/F
CL/F: apparent clearance
Measured: 85 days
PK Parameters Vz/F
Vz/F: apparent volume of distribution based on terminal phase
Measured: 85 days
PK parameters CLR
CLR: Renal clearance of drug from plasma
Measured: 85 days
PK parameters fe
fe: Percentage of dose excreted unchanged in urine
Measured: 85 days
PK parameters Ae
Amount of unchanged drug excreted into urine
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start16 Jun 2023
- Primary completion16 Sep 2024
- Study completion16 Sep 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled within the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6). Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Group 4: Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919069
- Sponsor's protocol ID
- D7830C00008
- Status last verified
- May 2026
- First submitted
- 16 Jun 2023
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of AZD2693.
- ClinicalTrials.gov ID
- NCT05919069
- Acronym / sponsor ID
- D7830C00008
- Conditions
- Hepatic Impairment
- Keywords
- Mild, Moderate, Severe, Healthy Matches
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 26 Jun 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.
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
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 AZD2693 administered as an subcutaneous injection in male and female participants with mild, moderate, or severe hepatic impairment compared with male and female participants with normal hepatic function (as control). Eight participants with mild impairment (CP Class A); 8 participants with moderate impairment (CP Class B); 8 participants with severe impairment (CP Class C); and 8 to12 participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired participants are planned for study intervention with the goal of having at least 6 evaluable participants within each group. Study participants who self-withdraw after study intervention may be replaced to ensure that at least 6 participants per group are evaluable and complete the study per protocol. An evaluable participant is defined as having adequate plasma PK profile to meet the primary study objective. Child-Pugh scoring, detailed in Table 2, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6).
Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Group 4: Participants with normal hepatic function.
Study Arms and Duration:
- Planned screening duration per participant: up to 4 weeks.
- Planned study duration (screening to follow-up) per participant: up to 16 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled within the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6). Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Group 4: Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AZD2693Participants with mild hepatic impairment (CP Class A, score of 5 or 6) |
| Group 2 | Experimental | Drug: AZD2693Participants with moderate hepatic impairment (CP Class B, score of 7 to 9) |
| Group 3 | Experimental | Drug: AZD2693Participants with severe hepatic impairment (CP Class C, score of 10 to 15) |
| Group 4 | Experimental | Drug: AZD2693Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant with a diagnosis of chronic and stable hepatic impairment
- Participant with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECGs,
- Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening
Key exclusion criteria (5 listed)
- Participant with impaired hepatic function has eGFR < 60 mL/minute/1.73 m2 and participant with normal hepatic function has eGFR < 90 mL/minute/1.73 m2
- Positive test for HIV at screening
- History or presence of clinically significant thyroid disease
- History or presence of clinically significant or unstable medical or psychiatric condition
- History of any major surgical procedure within 30 days prior to study intervention
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 |
|---|---|---|
| AZD2693Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
PK parameters AUCinf
Time frame: 85 days
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
PK parameters AUClast
Time frame: 85 days
area under the concentration-time curve from time zero to last time of quantifiable concentration
PK parameters Cmax
Time frame: 85 days
maximum observed plasma concentration
8 secondary outcomes
PK parameters tmax
Time frame: 85 days
PK parameters tlast
Time frame: 85 days
PK parameters t1/2λz
Time frame: 85 days
PK parameters CL/F
Time frame: 85 days
PK Parameters Vz/F
Time frame: 85 days
PK parameters CLR
Time frame: 85 days
PK parameters fe
Time frame: 85 days
PK parameters Ae
Time frame: 85 days
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 May 2026.
- Redacted CSR SynopsisLink provided by the sponsor.
- AZCTLink provided by the sponsor.
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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 AZD2693 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 6 inclusion and 5 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 May 2026. 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?
PK parameters AUCinf (time frame: 85 days). 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 11 May 2026.