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).
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
22
Camizestrant 75 mg tablets. Experimental drug.
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Sofia, Bulgaria
Research Site
Bratislava, Slovakia
PK parameters Cmax
Cmax: maximum concentration
Time frame: 5 days
PK parameters tmax
tmax : time to maximum concentration
Time frame: 5 days
PK parameters AUClast,
area under the concentration-time curve (AUC) from zero to the last measurable concentration (AUClast)
Time frame: 5 days
PK parameters AUCinf.;
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
Time frame: 5 days
PK parameters tlast
tlast: time of the last measurable concentration
Time frame: 5 days
PK parameters t1/2λz
t1/2λz: apparent terminal elimination half-life
Time frame: 5 days
PK parameters CL/F
CL/F: apparent clearance;
Time frame: 5 days
PK parameters Vz/F.
Vz/F: apparent volume of distribution.
Time frame: 5 days
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
Time frame: 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
Time frame: 4.5 weeks
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