A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: AZD2389

Study type: Interventional

Funder types: Industry

Identifiers

NCT06812780

D7930C00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched)

Treatment:

Drug: AZD2389

Cohort 2

Experimental group

Description:

Participants with mild hepatic impairment (CP A classification)

Treatment:

Drug: AZD2389

Cohort 3

Experimental group

Description:

Participants with moderate hepatic impairment (CP B classification)

Treatment:

Drug: AZD2389

Cohort 4

Experimental group

Description:

Participants with severe hepatic impairment (CP C classification)

Treatment:

Drug: AZD2389