Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participa… (NCT05126329) | Clinical Trial Compass
TerminatedPhase 1
Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function
Stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern
Germany, South Korea13 participantsStarted 2021-11-15
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexFEMALE
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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 participa…
What they're measuring
1
Pharmacokinetic (PK) assessment: Maximum plasma concentration observed (Cmax)
Timeframe: From Day 1 to Day 5
2
PK assessment: Area under the plasma concentration (AUC)