A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
Purpose
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.
Condition
- Hepatic Impairment
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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)
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched) |
|
|
Experimental Cohort 2 |
Participants with mild hepatic impairment (CP A classification) |
|
|
Experimental Cohort 3 |
Participants with moderate hepatic impairment (CP B classification) |
|
|
Experimental Cohort 4 |
Participants with severe hepatic impairment (CP C classification) |
|
Recruiting Locations
Rialto, California 92377
Miami Lakes, Florida 33014
Orlando, Florida 32809
San Antonio, Texas 78215
More Details
- NCT ID
- NCT06812780
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
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.