A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693

NCT ID: NCT05919069

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-09-16

Brief Summary

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Detailed Description

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD2693 administered as an subcutaneous injection in male and female participants with mild, moderate, or severe hepatic impairment compared with male and female participants with normal hepatic function (as control). Eight participants with mild impairment (CP Class A); 8 participants with moderate impairment (CP Class B); 8 participants with severe impairment (CP Class C); and 8 to12 participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired participants are planned for study intervention with the goal of having at least 6 evaluable participants within each group. Study participants who self-withdraw after study intervention may be replaced to ensure that at least 6 participants per group are evaluable and complete the study per protocol. An evaluable participant is defined as having adequate plasma PK profile to meet the primary study objective. Child-Pugh scoring, detailed in Table 2, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6).

Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).

Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).

Group 4: Participants with normal hepatic function.

Study Arms and Duration:

• Planned screening duration per participant: up to 4 weeks.
• Planned study duration (screening to follow-up) per participant: up to 16 weeks.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Participants with mild hepatic impairment (CP Class A, score of 5 or 6)

Group Type: EXPERIMENTAL

AZD2693

Intervention Type: DRUG

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Group 2

Participants with moderate hepatic impairment (CP Class B, score of 7 to 9)

Group Type: EXPERIMENTAL

AZD2693

Intervention Type: DRUG

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Group 3

Participants with severe hepatic impairment (CP Class C, score of 10 to 15)

Group Type: EXPERIMENTAL

AZD2693

Intervention Type: DRUG

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Group 4

Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups

Group Type: EXPERIMENTAL

AZD2693

Intervention Type: DRUG

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Interventions

AZD2693

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For Hepatic:

• Participant with a diagnosis of chronic and stable hepatic impairment

For Healthy:

• Participant with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or 12-lead ECGs,

All participants:

• Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening

Exclusion Criteria

• Participant with impaired hepatic function has eGFR < 60 mL/minute/1.73 m2 and participant with normal hepatic function has eGFR < 90 mL/minute/1.73 m2
• Positive test for HIV at screening
• History or presence of clinically significant thyroid disease
• History or presence of clinically significant or unstable medical or psychiatric condition
• History of any major surgical procedure within 30 days prior to study intervention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Rialto, California, United States

Research Site

Miami Lakes, Florida, United States

Research Site

Orlando, Florida, United States

Countries

United States

Other Identifiers

D7830C00008

Identifier Type: -

Identifier Source: org_study_id