Clinical trial NCT06812780: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
Official title: A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Mild
Moderate
Severe
Matched Healthy Controls
Liver Fibrosis
Liver Cirrhosis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be enrolled within the following groups based on their CP classification score as determined at screening: Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched)

* Cohort 2: Participants with mild hepatic impairment (CP A classification)
* Cohort 3: Participants with moderate hepatic impairment (CP B classification)
* Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

Detailed description: This is a single-dose, non-randomised, open-label, parallel-group study to examine the PK, fibroblast activation protein activity, safety, and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.

The study is planned to consist of:

* Cohort 1: Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched)
* Cohort 2: Participants with mild hepatic impairment (CP A classification)
* Cohort 3: Participants with moderate hepatic impairment (CP B classification)
* Cohort 4 (Optional): Participants with severe hepatic impairment (CP C classification)

Safety, tolerability, and available plasma PK data up to 48 hours post-dose from at least 4 participants in each of the mild hepatic impairment (CP Class A) and moderate hepatic impairment (CP Class B) cohorts must have been assessed by the investigator(s), medical monitor, and sponsor prior to the decision to proceed with evaluation/recruitment of participants with severe hepatic impairment (CP Class C). Cohort 1 (normal hepatic function) will be initiated in parallel with Cohorts 2 and 3.

Eligibility criteria: Inclusion Criteria:

For Hepatic:

* Participant with a diagnosis of stable hepatic impairment

For Healthy:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

All participants:

- Body weight ≥ 50 kg; BMI within the range of 18.0 to 42.0 kg/m2 (inclusive).

Exclusion Criteria:

* Participant has eGFR \< 60 mL/minute/1.73 m2
* Positive test for HIV at screening
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
* History of severe dermatological disorders

Primary outcomes:
measure: Plasma PK parameter Cmax
timeFrame: pre-dose to 48 hours post-dose
measure: Plasma PK parameter AUCinf
timeFrame: pre-dose to 48 hours post-dose
measure: Plasma PK parameter AUClast
timeFrame: pre-dose to 48 hours post-dose
Secondary outcomes:
measure: Plasma PK parameter t1/2λz
timeFrame: pre-dose to 48 hours post-dose
measure: Plasma PK parameter Tmax
timeFrame: pre-dose to 48 hours post-dose
measure: Plasma PK parameter CL/F
timeFrame: pre-dose to 48 hours post-dose
measure: Plasma PK parameter Vz/F
timeFrame: pre-dose to 48 hours post-dose
measure: Urine PK parameter Ae(t1-t2)
timeFrame: pre-dose to 48 hours post-dose
measure: Urine PK parameter CLr
timeFrame: pre-dose to 48 hours post-dose
measure: Urine PK parameters fe(t1-t2)
timeFrame: pre-dose to 48 hours post-dose
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Research Site
state: California
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
References: