Study identifier:D7260C00011
ClinicalTrials.gov identifier:NCT06813781
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004
Hepatic Impairment
Phase 1
Yes
AZD5004
All
32
Interventional
18 Years - 80 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
Fortrea Clinical Research Unit Inc.
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.
Location
Status
Location
Orlando, FL, United States, 32809
Status
Recruiting
Location
Lake Forest, CA, United States, 92630
Status
Recruiting
Location
Rialto, CA, United States, 92377
Status
Recruiting
Location
San Antonio, TX, United States, 78215
Status
Recruiting
Location
Miami Lakes, FL, United States, 33014
Status
Not yet recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Group 1 A single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |
Experimental: Group 2 A single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |
Experimental: Group 3 A single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |
Experimental: Group 4 A single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |
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