Hepatic Function AbnormalPhase 1NCT05126329
Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function
A Phase 1 study testing amcenestrant in people with Hepatic Function Abnormal, run by Sanofi at 3 sites in 2 countries.
Trial summary
This is a Phase 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Function Abnormal
- What is being tested?
- amcenestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Nov 2021to 16 May 2022
- 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For participants with hepatic impairment:
- Participant must be 40 to 75 years of age, inclusive.
- Female participants who are postmenopausal or are post-bilateral surgical oophorectomy not linked to a history of cancer. Menopause is defined as being amenorrheic for at least 12 months without an alternative medical cause, with plasma FSH level >30 IU/L or age ≥60 years.
- Stable chronic liver disease assessed by medical history, physical examination, laboratory values
- Body weight within the range 50 kg (40 kg for site in South Korea) to 110 kg and body mass index (BMI) within the range 18 to 36 kg/m2, inclusive.
- For moderate hepatic impairment cohort: Child-Pugh total score ranging from 7 to 9, inclusive.
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- For mild hepatic impairment cohort: Child-Pugh total score ranging from 5 to 6, inclusive
- For matched subjects:
- Participant must be 40 to 75 years of age, inclusive.
- Female participants who are postmenopausal or are post-bilateral surgical oophorectomy not linked to a history of cancer. Menopause is defined as being amenorrheic for at least 12 months without an alternative medical cause, with plasma FSH level >30 IU/L or age ≥60 years.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body weight within the range 50 kg (40 kg for site in South Korea) to 100 kg and body mass index (BMI) within the range 18 to 36 kg/m2, inclusive.
Who cannot join
- For participants with hepatic impairment:
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis) within 1 year before inclusion.
- Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization (Smoking is not allowed within 8 hours after amcenestrant administration).
- Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
- Non-live vaccines including Covid-19: last administration of a vaccine within 1 week (symptoms-free) to 2 weeks before inclusion.
- Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
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- Use of any herbal medicines 1 week before IMP administration and up to the end of PK sampling following the IMP administration
- Live-vaccines: last administration of a vaccine within 4 weeks before inclusion
- Treatment with a strong CYP3A, CYP2C8 or any UGTs inhibitor within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- Treatment with a strong or moderate CYP3A, CYP2C8 or any UGTs inducer within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic, renal, infectious disease, severe hepatic impairment (Child-Pugh total score greater than or equal to 10), or signs of acute illness, hepatocarcinoma, acute hepatitis, Hepatic encephalopathy Grade 2, 3, and 4
- Esophageal bleeding, which is caused by esophageal varices, within 3 months before inclusion
- For matched subjects:
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis) within 1 year before inclusion.
- Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization (Smoking is not allowed within 8 hours after amcenestrant administration).
- Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic, or infectious disease, or signs of acute illness, unless the Investigator considers an abnormality to be not clinically significant.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month.
- Non-live vaccines including Covid-19: last administration of a vaccine within 1 week (symptoms-free) to 2 weeks before inclusion
- Live-vaccines: last administration of a vaccine within 4 weeks before inclusion
- Treatment with a strong CYP3A, CYP2C8 or any UGTs inhibitor within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- Treatment with a strong or moderate CYP3A, CYP2C8 or any UGTs inducer within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
- Use of any herbal medicines 1 week before IMP administration and up to the end of PK sampling following the IMP administration The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Korea2 sites
Investigational site number :4100002
Cheongju-si, 28644
Investigational Site Number :4100001
Seoul, Seoul-teukbyeolsi, 03080
About this study
Official title: An Open-label Pharmacokinetic and Tolerability Study of Amcenestrant Given as a Single Dose in Female Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function
This is a Phase 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched participants with normal hepatic function.
Read the detailed description
The total study duration from screening period is approximately 41 days.
- Conditions
- Hepatic Function Abnormal
- Being tested
- amcenestrant
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amcenestrantDrug
tablet for oral use
| Study group | Role | What they receive |
|---|---|---|
| Participants with mild hepatic impairment | Experimental | Amcenestrant 200 mg single dose on Day 1 in fed condition Receives: Drug: amcenestrant |
| Participants with moderate hepatic impairment | Experimental | Amcenestrant 200 mg single dose on Day 1 in fed condition Receives: Drug: amcenestrant |
| Participants with normal hepatic function | Experimental | Amcenestrant 200 mg single dose on Day 1 in fed condition Receives: Drug: amcenestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) assessment: Maximum plasma concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of amcenestrant
Measured: From Day 1 to Day 5
PK assessment: Area under the plasma concentration (AUC)
Area under the plasma concentration versus time curve of amcenestrant
Measured: From Day 1 to Day 5
Secondary outcomes (8)
PK assessment: Tmax of amcenestrant
Time to reach Cmax of amcenestrant
Measured: From Day 1 to Day 5
PK assessment: Area under the plasma concentration versus time curve (AUClast) of amcenestrant
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast of amcenestrant
Measured: From Day 1 to Day 5
PK assessment: Maximum unbound plasma concentration (Cmax u) of amcenestrant
Maximum unbound plasma concentration of amcenestrant
Measured: From Day 1 to Day 5
PK assessment: AUCu of amcenestrant
Unbound area under the plasma concentration versus time curve extrapolated to infinity of amcenestrant
Measured: From Day 1 to Day 5
PK assessment: Cmax of M7
Maximum observed plasma concentration of M7
Measured: From Day 1 to Day 5
PK assessment: AUClast of M7
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast of M7
Measured: From Day 1 to Day 5
PK assessment: AUC of M7
Area under the plasma concentration versus time curve extrapolated to infinity of M7
Measured: From Day 1 to Day 5
Number of participants with adverse events (AEs) / treatment-emergent adverse events (TEAEs)
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Measured: From the date when the ICF is signed to the end of study (approximately Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start15 Nov 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Why it stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Function AbnormalStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126329
- Sponsor's protocol ID
- POP16301
- Other IDs
- U1111-1244-1929, 2021-001784-24
- Status last verified
- Sep 2025
- First submitted
- 3 Nov 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic and Tolerability Study of Amcenestrant Given as a Single Dose in Female Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT05126329
- Acronym / sponsor ID
- POP16301
- Conditions
- Hepatic Function Abnormal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern
- Enrolment
- 13 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 19 Nov 2021 (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 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched participants with normal hepatic function.
Detailed description
The total study duration from screening period is approximately 41 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with mild hepatic impairment | Experimental | Drug: amcenestrantAmcenestrant 200 mg single dose on Day 1 in fed condition |
| Participants with moderate hepatic impairment | Experimental | Drug: amcenestrantAmcenestrant 200 mg single dose on Day 1 in fed condition |
| Participants with normal hepatic function | Experimental | Drug: amcenestrantAmcenestrant 200 mg single dose on Day 1 in fed condition |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant must be 40 to 75 years of age, inclusive.
- Female participants who are postmenopausal or are post-bilateral surgical oophorectomy not linked to a history of cancer. Menopause is defined as being amenorrheic for at least 12 months without an alternative medical cause, with plasma FSH level >30 IU/L or age ≥60 years.
- Stable chronic liver disease assessed by medical history, physical examination, laboratory values
- Body weight within the range 50 kg (40 kg for site in South Korea) to 110 kg and body mass index (BMI) within the range 18 to 36 kg/m2, inclusive.
- For moderate hepatic impairment cohort: Child-Pugh total score ranging from 7 to 9, inclusive.
Key exclusion criteria (24 listed)
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis) within 1 year before inclusion.
- Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization (Smoking is not allowed within 8 hours after amcenestrant administration).
- Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
- Non-live vaccines including Covid-19: last administration of a vaccine within 1 week (symptoms-free) to 2 weeks before inclusion.
- Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
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 |
|---|---|---|
| amcenestranttablet for oral use | Drug | Participants with mild hepatic impairment, Participants with moderate hepatic impairment, Participants with normal hepatic function |
Primary outcome
Pharmacokinetic (PK) assessment: Maximum plasma concentration observed (Cmax)
Time frame: From Day 1 to Day 5
Maximum plasma concentration observed (Cmax) of amcenestrant
PK assessment: Area under the plasma concentration (AUC)
Time frame: From Day 1 to Day 5
Area under the plasma concentration versus time curve of amcenestrant
8 secondary outcomes
PK assessment: Tmax of amcenestrant
Time frame: From Day 1 to Day 5
PK assessment: Area under the plasma concentration versus time curve (AUClast) of amcenestrant
Time frame: From Day 1 to Day 5
PK assessment: Maximum unbound plasma concentration (Cmax u) of amcenestrant
Time frame: From Day 1 to Day 5
PK assessment: AUCu of amcenestrant
Time frame: From Day 1 to Day 5
PK assessment: Cmax of M7
Time frame: From Day 1 to Day 5
PK assessment: AUClast of M7
Time frame: From Day 1 to Day 5
PK assessment: AUC of M7
Time frame: From Day 1 to Day 5
Number of participants with adverse events (AEs) / treatment-emergent adverse events (TEAEs)
Time frame: From the date when the ICF is signed to the end of study (approximately Day 10)
Results and safety
The study was stopped early (reason given: Sponsor decision to prematurely stop the study, not linked to any safety concern). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- POP16301 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing amcenestrant in people with Hepatic Function Abnormal, run by Sanofi at 3 sites in 2 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 12 inclusion and 24 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: stopped early, as of the sponsor's last update on 22 Sep 2025. 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 South Korea, Germany. 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 was stopped early (reason given: Sponsor decision to prematurely stop the study, not linked to any safety concern). Results are not available in the source record.
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?
Pharmacokinetic (PK) assessment: Maximum plasma concentration observed (Cmax) (time frame: From Day 1 to Day 5). The study lists 2 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 22 Sep 2025.