Clinical Trial: NCT07154901
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-06-26 |
Study Overview
Brief Summary
This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to participants with normal renal function.
Official Title
A Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Conditions
Renal Impairment
Intervention / Treatment
- Drug: Opemalirsen (AZD2373)
Other Study ID Numbers
- D6800C00006
Start Date (Actual)
2025-08-18
Primary Completion Date (Actual)
2026-06-15
Study Completion Date (Actual)
2026-06-15
Enrollment (Actual)
35
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | AstraZeneca |
| Information Provided By: | AstraZeneca |
| Last Update Posted: | 2026-06-26 |
Study Overview
Brief Summary
This study is being conducted to investigate the PK, safety, and tolerability of opemalirsen in participants with renal impairment, compared to participants with normal renal function.
Official Title
A Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Conditions
Renal Impairment
Intervention / Treatment
- Drug: Opemalirsen (AZD2373)
Other Study ID Numbers
- D6800C00006
Start Date (Actual)
2025-08-18
Primary Completion Date (Actual)
2026-06-15
Study Completion Date (Actual)
2026-06-15
Enrollment (Actual)
35
Study Type
Interventional
Phase
Phase 1