Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function

NCT ID: NCT05126329

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-05-16

Brief 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.

Detailed Description

The total study duration from screening period is approximately 41 days.

Conditions

Hepatic Function Abnormal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with mild hepatic impairment

Amcenestrant 200 mg single dose on Day 1 in fed condition

Group Type: EXPERIMENTAL

amcenestrant

Intervention Type: DRUG

tablet for oral use

Participants with moderate hepatic impairment

Amcenestrant 200 mg single dose on Day 1 in fed condition

Group Type: EXPERIMENTAL

amcenestrant

Intervention Type: DRUG

tablet for oral use

Participants with normal hepatic function

Amcenestrant 200 mg single dose on Day 1 in fed condition

Group Type: EXPERIMENTAL

amcenestrant

Intervention Type: DRUG

tablet for oral use

Interventions

amcenestrant

tablet for oral use

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.
• 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.

Exclusion Criteria

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.
• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number :2760001

Kiel, , Germany

Investigational Site Number :4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational site number :4100002

Cheongju-si, , South Korea

Countries

Germany; South Korea

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25331&tenant=MT_SNY_9011

POP16301 Plain Language Results Summary

Other Identifiers

U1111-1244-1929

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-001784-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

POP16301

Identifier Type: -

Identifier Source: org_study_id