This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of AZD0780 with moderate and possibly mild hepatic impairment in comparison to a matched healthy control group.
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD0780 dose 1 administered orally to male and female participants (females of non-childbearing potential) with moderate hepatic impairment and mild hepatic impairment (optional) compared with male and female participants (females of non-childbearing potential) with normal hepatic function. Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening: * Group 1: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9). * Group 2: Participants with normal hepatic function demographically matched by sex, age, and body mass index (BMI) to the impaired participants. * Group 3 (optional): Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Dose 1
Research Site
Hialeah, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
San Antonio, Texas, United States
AUClast
Area under plasma concentration-time curve from time zero to the last measurable concentration
Time frame: Day 1 to Day 11
AUCinf
Area under plasma concentration-time curve from zero to infinity
Time frame: Day 1 to Day 11
Cmax
Maximum observed plasma concentration
Time frame: Day 1 to Day 11
Number of participants with adverse events (AEs)
To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function
Time frame: Day 1 to Day 11
Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings
To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function
Time frame: Day 1 to Day 11
Number of participants with abnormal laboratory tests results
To assess the safety and tolerability of a single oral dose of AZD0780 in participants with moderate and mild (optional) hepatic impairment and those with normal hepatic function
Time frame: Day 1 to Day 11
Tmax
Time to reach maximum observed plasma concentration
Time frame: Day 1 to Day 11
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PK parameters (t1/2λz)
Terminal elimination half-life
Time frame: Day 1 to Day 11
PK parameters (CL/F)
Apparent plasma clearance
Time frame: Day 1 to Day 11
PK parameters (Vz/F)
Apparent volume of distribution during the terminal phase
Time frame: Day 1 to Day 11
PK parameters (AUC0-96)
Area under the plasma concentration-time curve from time zero to 96 hours
Time frame: Day 1 to Day 5
PK parameters (CLR)
Renal clearance of drug from plasma
Time frame: Day 1 to Day 11
PK parameters (Ae)
Amount excreted in urine
Time frame: Day 1 to Day 11
PK parameters (fe)
Fraction of dose excreted in urine
Time frame: Day 1 to Day 11