Clinical trial · Interventional
A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693
A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of AZD2693.
NCT05919069CI-TRIAL-00111085completedPhase 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)
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
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 |
|---|---|---|---|
| AZD2693 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Participants with mild hepatic impairment (CP Class A, score of 5 or 6)
- interventionNames
- Drug: AZD2693
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Participants with moderate hepatic impairment (CP Class B, score of 7 to 9)
- interventionNames
- Drug: AZD2693
- type
- EXPERIMENTAL
- label
- Group 3
- description
- Participants with severe hepatic impairment (CP Class C, score of 10 to 15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.