The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).
This is a single dose, non-randomized, open-label, parallel group study. A Screening Period (Day -21 to -2): Participants in moderate impairment group will have an additional assessment of hepatic function stability on Day -7. Treatment and Residential Period: Participants will be resident at the Investigative Site from Day -1 to Day 4 and will receive a single oral dose of capivasertib on Day 1. Follow-up Period: Participants will return for a follow-up visit on Days 9 to 11.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Capivasertib will be administered orally
Research Site
Rialto, California, United States
RECRUITINGResearch Site
San Antonio, Texas, United States
NOT_YET_RECRUITINGArea under concentration time curve from zero to infinity (AUCinf)
To compare the PK (AUCinf) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To compare the PK (AUClast) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Maximum plasma drug concentration (Cmax)
To compare the PK (Cmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Concentration of capivasertib in plasma over time
To compare the plasma concentration of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-t)
To compare the PK (AUC0-t) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Time to Cmax (tmax)
To compare the PK (tmax) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
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Time frame: From Day 1 to Day 4
Terminal half-life (t½)
To compare the PK (t½) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Apparent plasma clearance (CL/F)
To compare the PK (CL/F) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Renal Clearance (CLR)
To compare the PK (CLR) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 3
Apparent volume of distribution (Vz/F)
To compare the PK (Vz/F) of a single oral dose of capivasertib in participants with moderate hepatic impairment to participants with normal hepatic function.
Time frame: From Day 1 to Day 4
Number of participants with Adverse Events (AEs) and Serious AEs
To examine the safety and tolerability of a single oral dose of capivasertib in participants with moderate hepatic impairment and in those with normal hepatic function.
Time frame: Up to Day 11