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

NCT05919069 | Completed Phase 1 FDA Drug

• 1 other identifier: D7830C00008
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Conditions

Hepatic Impairment

Keywords

Mild; Moderate; Severe; Healthy Matches

Outcome Measures

Primary Outcomes (3)

• PK parameters AUCinf

  area under the concentration-time curve (AUC) from zero to infinity (AUCinf)

  85 days

• PK parameters AUClast

  area under the concentration-time curve from time zero to last time of quantifiable concentration

  85 days

• PK parameters Cmax

  maximum observed plasma concentration

  85 days

Secondary Outcomes (8)

• PK parameters tmax

  85 days

• PK parameters tlast

  85 days

• PK parameters t1/2λz

  85 days

• PK parameters CL/F

  85 days

• PK Parameters Vz/F

  85 days

Study Arms (4)

Group 1

EXPERIMENTAL

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

Drug: AZD2693

Group 2

EXPERIMENTAL

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

Drug: AZD2693

Group 3

EXPERIMENTAL

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

Drug: AZD2693

Group 4

EXPERIMENTAL

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

Drug: AZD2693

Interventions

AZD2693 DRUG

Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 75 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Rialto, California, 92377, United States

Location

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

Orlando, Florida, 32808, United States

Location

Related Links

• Redacted CSR Synopsis

MeSH Terms

Conditions

Lymphoma, Follicular

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

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: 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 matched on a group level regarding age, body weight, and sex to the impaired groups

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: June 16, 2023
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (3)