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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: AZD2389

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Research Site
  • California
    • Rialto, California, United States, 92377
      • Research Site
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Research Site
    • Orlando, Florida, United States, 32809
      • Research Site
  • Texas
    • San Antonio, Texas, United States, 78215
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched)	Drug: AZD2389; Single oral dose of AZD2389 in participants from all cohorts
Experimental: Cohort 2; Participants with mild hepatic impairment (CP A classification)	Drug: AZD2389; Single oral dose of AZD2389 in participants from all cohorts
Experimental: Cohort 3; Participants with moderate hepatic impairment (CP B classification)	Drug: AZD2389; Single oral dose of AZD2389 in participants from all cohorts
Experimental: Cohort 4; Participants with severe hepatic impairment (CP C classification)	Drug: AZD2389; Single oral dose of AZD2389 in participants from all cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK parameter Cmax	maximum observed plasma concentration	pre-dose to 48 hours post-dose
Plasma PK parameter AUCinf	area under the concentration-time curve from zero to infinity	pre-dose to 48 hours post-dose
Plasma PK parameter AUClast	area under the concentration-time curve from zero to the last measurable concentration	pre-dose to 48 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK parameter t1/2λz	half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve	pre-dose to 48 hours post-dose
Plasma PK parameter Tmax	time to reach maximum observed plasma concentration	pre-dose to 48 hours post-dose
Plasma PK parameter CL/F	apparent total body clearance of drug from plasma after extravascular administration	pre-dose to 48 hours post-dose
Plasma PK parameter Vz/F	apparent volume of distribution during the terminal phase after extravascular administration.	pre-dose to 48 hours post-dose
Urine PK parameter Ae(t1-t2)	cumulative amount of unchanged drug excreted into the urine for the interval between time 1 and time 2	pre-dose to 48 hours post-dose
Urine PK parameter CLr	renal clearance of the drug from plasma	pre-dose to 48 hours post-dose
Urine PK parameters fe(t1-t2)	fraction of the drug excreted into the urine for the interval between time 1 and time 2	pre-dose to 48 hours post-dose

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Actual): September 4, 2025
• Study Completion (Actual): September 4, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Severe; Moderate; Liver Fibrosis; Mild; Matched Healthy Controls
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Digestive System Diseases; Liver Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Fibrosis; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Liver Cirrhosis
• Other Study ID Numbers: D7930C00004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No