Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatic Function Abnormal

Outcome Measures

Primary Outcomes (2)

Pharmacokinetic (PK) assessment: Maximum plasma concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of amcenestrant
From Day 1 to Day 5
PK assessment: Area under the plasma concentration (AUC)
Area under the plasma concentration versus time curve of amcenestrant
From Day 1 to Day 5

Secondary Outcomes (8)

PK assessment: Tmax of amcenestrant
From Day 1 to Day 5
PK assessment: Area under the plasma concentration versus time curve (AUClast) of amcenestrant
From Day 1 to Day 5
PK assessment: Maximum unbound plasma concentration (Cmax u) of amcenestrant
From Day 1 to Day 5
PK assessment: AUCu of amcenestrant
From Day 1 to Day 5
PK assessment: Cmax of M7
From Day 1 to Day 5
+3 more secondary outcomes

Study Arms (3)

Participants with mild hepatic impairment

EXPERIMENTAL

Amcenestrant 200 mg single dose on Day 1 in fed condition

Drug: amcenestrant

Participants with moderate hepatic impairment

EXPERIMENTAL

Amcenestrant 200 mg single dose on Day 1 in fed condition

Drug: amcenestrant

Participants with normal hepatic function

EXPERIMENTAL

Amcenestrant 200 mg single dose on Day 1 in fed condition

Interventions

amcenestrantDrug

tablet for oral use

Participants with mild hepatic impairmentParticipants with moderate hepatic impairmentParticipants with normal hepatic function

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 75 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

For participants with hepatic impairment:
Participant must be 40 to 75 years of age, inclusive.

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (3)

Investigational Site Number :2760001

Kiel, 24105, Germany

Investigational Site Number :4100001

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Investigational site number :4100002

Cheongju-si, 28644, South Korea

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

Clinical Sciences & Operations
Sanofi
STUDY DIRECTOR

Enrollment

13 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 3, 2021

First Posted

November 19, 2021

Study Start

November 15, 2021

Actual (reported)

You may not qualify if:

For participants with hepatic impairment:
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).
Use of any herbal medicines 1 week before IMP administration and up to the end of PK sampling following the IMP administration
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
For matched subjects:
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.
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.
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

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (3)

Participants with mild hepatic impairment

Participants with moderate hepatic impairment

Participants with normal hepatic function

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (3)

Participants with mild hepatic impairment

Participants with moderate hepatic impairment

Participants with normal hepatic function

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations