This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, and severe hepatic impairment compared with participants with normal hepatic function.
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with mild, moderate, or severe hepatic impairment compared with participants 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 mild hepatic impairment (Child Pugh Class A, score of 5 or 6). Group 2: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9). Group 3: Participants with severe hepatic impairment (Child Pugh Class C, score of 10 to 15). Group 4: Participants with normal hepatic function matched on a group level regarding sex, age, and body weight to the impaired participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Dose 1
Research Site
Lake Forest, California, United States
Research Site
Rialto, California, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Orlando, Florida, United States
AUCinf
Area under plasma concentration-time curve from zero to infinity
Time frame: Day 1 to Day 6
AUClast
Area under plasma concentration-time curve from time zero to the last measurable concentration
Time frame: Day 1 to Day 6
Cmax
Maximum observed plasma concentration
Time frame: Day 1 to Day 6
Tmax
Time to reach maximum observed plasma concentration
Time frame: Day 1 to Day 6
PK parameters (t1/2λz)
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve
Time frame: Day 1 to Day 6
PK parameters CL/F
Apparent total body clearance of drug from plasma after extravascular administration
Time frame: Day 1 to Day 6
PK parameters CLNR/F
Non-renal clearance of drug from plasma after oral administration
Time frame: Day 1 to Day 6
PK parameter Vz/F
Apparent volume of distribution during the terminal phase after extravascular administration
Time frame: Day 1 to Day 6
PK parameter CLr
Renal clearance of the drug from plasma
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
San Antonio, Texas, United States
Time frame: Day 1 to Day 6
PK parameter Ae
Cumulative amount of unchanged drug excreted into the urine
Time frame: Day 1 to Day 6
fe
Fraction of the drug excreted into the urine
Time frame: Day 1 to Day 6