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

NCT06812780 | Completed Phase 1 FDA Drug

• 1 other identifier: D7930C00004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

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.

Conditions

Hepatic Impairment

Keywords

Mild; Moderate; Severe; Matched Healthy Controls; Liver Fibrosis; Liver Cirrhosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Plasma PK parameter t1/2λz

  pre-dose to 48 hours post-dose

• Plasma PK parameter Tmax

  pre-dose to 48 hours post-dose

• Plasma PK parameter CL/F

  pre-dose to 48 hours post-dose

• Plasma PK parameter Vz/F

  pre-dose to 48 hours post-dose

• Urine PK parameter Ae(t1-t2)

  pre-dose to 48 hours post-dose

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: AZD2389

Cohort 2

EXPERIMENTAL

Participants with mild hepatic impairment (CP A classification)

Drug: AZD2389

Cohort 3

EXPERIMENTAL

Participants with moderate hepatic impairment (CP B classification)

Drug: AZD2389

Cohort 4

EXPERIMENTAL

Participants with severe hepatic impairment (CP C classification)

Drug: AZD2389

Interventions

AZD2389 DRUG

Single oral dose of AZD2389 in participants from all cohorts

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Chandler, Arizona, 85225, United States

Location

Research Site

Rialto, California, 92377, United States

Location

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

Orlando, Florida, 32809, United States

Location

Research Site

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: February 4, 2025
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (5)