Clinical trial · Interventional
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
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)
NCT06812780CI-TRIAL-00095722CAMPOLINAcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Impairment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD2389 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Participants with normal hepatic function (sex-, age-, and body mass index \[BMI\]-matched)
- interventionNames
- Drug: AZD2389
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Participants with mild hepatic impairment (CP A classification)
- interventionNames
- Drug: AZD2389
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Participants with moderate hepatic impairment (CP B classification)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.