Hepatic ImpairmentPhase 1NCT05790304
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
A Phase 1 study testing Camizestrant in people with Hepatic Impairment, run by AstraZeneca at 4 sites in 3 countries.
Trial summary
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic… Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Camizestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 20 Feb 2023to 22 Feb 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 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For participant with hepatic impairment: Participant must be 50 to 75 years of age, inclusive, at the time of signing the informed consent.
- -. For participant with normal hepatic function: Participant must be matched to participant with hepatic impairment by age (±10 years; determined at the time of signing the informed consent).
- For participant with hepatic impairment:
- Participant must have medical history, physical examination, vital signs, ECGs, and laboratory safety tests consistent with a diagnosis of hepatic impairment, but is otherwise judged to be in good health as determined by the investigator at screening and Day -1.
- Participant must have a diagnosis of chronic (>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any aetiology at screening and Day -1.
- For participant with normal hepatic function: Participants must be medically healthy with no clinically significant medical history, physical examination, laboratory profiles (including serum amylase and lipase, haematology, and thyroid function), vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1
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- For participant with hepatic impairment: Body weight within 50 to 100 kg and BMI within the range 19.0 to 35.0 kg/m2 (inclusive) as measured at screening.
- For participant with normal hepatic function: Participant must be matched to participant with hepatic impairment by weight in kg (±20%; data obtained at screening).
- Female, post-menopausal. (a) Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of study intervention without an alternative medical or surgical cause, confirmed by an FSH result of ≥ 30 IU/L obtained at screening.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) from screening, throughout the study, and for 2 weeks after the dose of study drug
Who cannot join
- History of or ongoing, clinically significant, in the opinion of the investigator, visual disturbances including, but not limited to, visual hallucinations, migraine with visual symptoms, blurred vision, and frequent floaters/flashes associated with other symptoms such as dizziness at screening or Day -1
- History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the investigator at screening or Day -1
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening or Day -1 visit or expected during the conduct of the study
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study noted at screening or Day -1
- Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infections (including upper respiratory tract infections, but excluding localized cutaneous fungal infections), in the opinion of the investigator at screening or Day -1
- History of any major surgical procedure within 30 days prior to the dose of study drug
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- Any clinically significant condition that may affect camizestrant absorption in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass), noted at screening or Day -1
- Signs or confirmation of COVID-19 infection at screening or Day -1
- Unable to refrain from or anticipates the use of:
- Any drugs known to prolong QT interval or drugs associated with a known risk of Torsades de pointes within 4 weeks or 5 PK half-lives (whichever is longer) prior to the dose of study drug and throughout the study.
- Use of any prescribed or non-prescribed medication
- Any drug known to be moderate or strong inhibitors or inducers of CYP3A and/or P-gp, including St. John's Wort, within 14 and 28 days, respectively, prior to the dose of study drug and throughout the study unless they are deemed acceptable following consultation with the sponsor medical monitor and the investigator.
- Human immunodeficiency virus protease inhibitor, anticoagulant within 14 days prior to the dose of study drug and throughout the study.
- Acetaminophen and ethacrynic acid within 24 hours prior to the dose of study drug and throughout the study.
- Dosed in another clinical trial within 28 days or 5 half-lives (if known), whichever is longer, prior to the dose of study drug
- Previous enrolment in the present study.
- Any clinically significant abnormalities at screening or Day -1 on 12-lead ECG as judged by the investigator
- Known history of hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant noted at screening or Day -1
- Donation of blood > 500 mL or significant blood loss within 56 days prior to the dose of study drug
- Plasma donation within 28 days prior to the dose of study drug.
- Is working at or has an immediate family member (spouse or children) who works at the investigational site or is a sponsor staff directly involved with this study."
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)."
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Participants with hepatic impairment are excluded from the study if any of the following criteria apply:
- History or presence of drug abuse within the past 2 years prior to screening.
- Positive results for the alcohol test and/or urine drug screen at screening or Day -1
- Positive results at screening for hepatitis B surface antigen or HCV
- Known history of HIV
- Participant has evidence of hepatorenal syndrome or creatinine clearance < 60 mL/minute
- History of unstable diabetes mellitus
- Presence of transjugular intrahepatic portosystemic shunt."
- Participants with normal hepatic function are excluded from the study if any of the following criteria apply:
- History or presence of clinically significant thyroid disease
- History or presence of alcoholism and/or drug abuse within the past 2 years prior to screening.
- Positive results for the alcohol test and/or urine drug screen at screening or Day -1
- Known history of HIV, positive results at screening for hepatitis B surface antigen or HCV.
- Participant has creatinine clearance <80 mL/minute
- Supine blood pressure < 90/40 mmHg or > 150/95 mmHg at screening or Day -1.
- Supine pulse rate < 50 bpm or > 99 bpm at screening or Day -1.
- Haemoglobin level below the lower limit of normal at screening or Day -1
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Research Site
San Antonio, Texas, 78215
Research Site
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Single Dose, Non-Randomised, Multicentre, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Camizestrant in Post Menopausal Female Subjects
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic function.
Participants will be enrolled within the following groups based on their CP classification score as determined at screening:
- Group 1: Matched-control healthy participants with normal hepatic function.
- 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).
Read the detailed description
This will be an open-label, non-randomized, multicentre, parallel-group, single-dose study to investigate the PK, safety, and tolerability of camizestrant 75 mg administered orally to post-menopausal female participants with moderate or severe hepatic impairment compared to control post-menopausal female participants with normal hepatic function. A total of approximately 14 participants with hepatic impairment (8 participants with moderate impairment and 6 participants with severe impairment per CP classification) and 8 to 14 matched-control healthy participants with normal hepatic function are planned to be enrolled, with the goal of having approximately 8 participants with moderate impairment and approximately 6 participants with severe impairment and sufficient matching participants with normal hepatic function complete the study. All participants will receive a single oral dose of 75 mg camizestrant on Day 1 following an overnight fast. Study intervention will be administered orally with approximately 240 mL of water.
Child-Pugh scoring, detailed in Table 3, 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: Matched-control healthy participants with normal hepatic function.
- 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).
- Conditions
- Hepatic Impairment
- Being tested
- Camizestrant
- Keywords
- hepatic impairment, Moderate, Severe
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamizestrantDrug
Also called AZD9833
Camizestrant 75 mg tablets. Experimental drug.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Matched-control healthy participants with normal hepatic function. Receives: Drug: Camizestrant |
| Group 2 | Other | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Receives: Drug: Camizestrant |
| Group 3 | Other | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Receives: Drug: Camizestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters Cmax
Cmax: maximum concentration
Measured: 5 days
PK parameters tmax
tmax : time to maximum concentration
Measured: 5 days
PK parameters AUClast,
area under the concentration-time curve (AUC) from zero to the last measurable concentration (AUClast)
Measured: 5 days
PK parameters AUCinf.;
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
Measured: 5 days
PK parameters tlast
tlast: time of the last measurable concentration
Measured: 5 days
PK parameters t1/2λz
t1/2λz: apparent terminal elimination half-life
Measured: 5 days
PK parameters CL/F
CL/F: apparent clearance;
Measured: 5 days
PK parameters Vz/F.
Vz/F: apparent volume of distribution.
Measured: 5 days
Secondary outcomes (2)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
The number of participants with adverse events (AEs) and serious adverse events (SAEs) to assess the safety
Measured: 4.5 weeks
Number of participants with an AE causally related to IMP leading to study discontinuation
Number of participants with an AE causally related to IMP leading to study discontinuation to assess the tolerability
Measured: 4.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start20 Feb 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 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: Matched-control healthy participants with normal hepatic function. * 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).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790304
- Sponsor's protocol ID
- D8532C00002
- Other IDs
- 2022-502277-41-00
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2023
- Last updated
- 25 Mar 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 request 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Dose, Non-Randomised, Multicentre, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Camizestrant in Post Menopausal Female Subjects
- ClinicalTrials.gov ID
- NCT05790304
- Acronym / sponsor ID
- D8532C00002
- Conditions
- Hepatic Impairment
- Keywords
- hepatic impairment, Moderate, Severe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 30 Mar 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.
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic function.
Participants will be enrolled within the following groups based on their CP classification score as determined at screening:
- Group 1: Matched-control healthy participants with normal hepatic function.
- 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).
Detailed description
This will be an open-label, non-randomized, multicentre, parallel-group, single-dose study to investigate the PK, safety, and tolerability of camizestrant 75 mg administered orally to post-menopausal female participants with moderate or severe hepatic impairment compared to control post-menopausal female participants with normal hepatic function. A total of approximately 14 participants with hepatic impairment (8 participants with moderate impairment and 6 participants with severe impairment per CP classification) and 8 to 14 matched-control healthy participants with normal hepatic function are planned to be enrolled, with the goal of having approximately 8 participants with moderate impairment and approximately 6 participants with severe impairment and sufficient matching participants with normal hepatic function complete the study. All participants will receive a single oral dose of 75 mg camizestrant on Day 1 following an overnight fast. Study intervention will be administered orally with approximately 240 mL of water.
Child-Pugh scoring, detailed in Table 3, 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: Matched-control healthy participants with normal hepatic function.
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be enrolled within the following groups based on their CP classification score as determined at screening: * Group 1: Matched-control healthy participants with normal hepatic function. * 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: CamizestrantMatched-control healthy participants with normal hepatic function. |
| Group 2 | Other | Drug: CamizestrantParticipants with moderate hepatic impairment (CP Class B, score of 7 to 9). |
| Group 3 | Other | Drug: CamizestrantParticipants with severe hepatic impairment (CP Class C, score of 10 to 15). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For participant with hepatic impairment: Participant must be 50 to 75 years of age, inclusive, at the time of signing the informed consent.
- -. For participant with normal hepatic function: Participant must be matched to participant with hepatic impairment by age (±10 years; determined at the time of signing the informed consent).
- For participant with hepatic impairment:
- For participant with normal hepatic function: Participants must be medically healthy with no clinically significant medical history, physical examination, laboratory profiles (including serum amylase and lipase, haematology, and thyroid function), vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1
- For participant with hepatic impairment: Body weight within 50 to 100 kg and BMI within the range 19.0 to 35.0 kg/m2 (inclusive) as measured at screening.
Key exclusion criteria (40 listed)
- History of or ongoing, clinically significant, in the opinion of the investigator, visual disturbances including, but not limited to, visual hallucinations, migraine with visual symptoms, blurred vision, and frequent floaters/flashes associated with other symptoms such as dizziness at screening or Day -1
- History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the investigator at screening or Day -1
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening or Day -1 visit or expected during the conduct of the study
- History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study noted at screening or Day -1
- Presence of any clinically significant, ongoing systemic bacterial, fungal, or viral infections (including upper respiratory tract infections, but excluding localized cutaneous fungal infections), in the opinion of the investigator 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 |
|---|---|---|
| CamizestrantAlso: AZD9833Camizestrant 75 mg tablets. Experimental drug. | Drug | Group 1, Group 2, Group 3 |
Primary outcome
PK parameters Cmax
Time frame: 5 days
Cmax: maximum concentration
PK parameters tmax
Time frame: 5 days
tmax : time to maximum concentration
PK parameters AUClast,
Time frame: 5 days
area under the concentration-time curve (AUC) from zero to the last measurable concentration (AUClast)
PK parameters AUCinf.;
Time frame: 5 days
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
PK parameters tlast
Time frame: 5 days
tlast: time of the last measurable concentration
PK parameters t1/2λz
Time frame: 5 days
t1/2λz: apparent terminal elimination half-life
PK parameters CL/F
Time frame: 5 days
CL/F: apparent clearance;
PK parameters Vz/F.
Time frame: 5 days
Vz/F: apparent volume of distribution.
2 secondary outcomes
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: 4.5 weeks
Number of participants with an AE causally related to IMP leading to study discontinuation
Time frame: 4.5 weeks
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 25 Mar 2025.
- D8532C00002\_CSR Synopsis\_redactedLink provided by the sponsor.
- astrazenecaclinicaltrails.com study resultsLink provided by the sponsor.
- 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 request 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Camizestrant in people with Hepatic Impairment, run by AstraZeneca at 4 sites in 3 countries.
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 40 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 25 Mar 2025. 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, Bulgaria, Slovakia. 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 Cmax (time frame: 5 days). The study lists 8 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 25 Mar 2025.