Trials / Completed
CompletedNCT03159416
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
A Single-Dose, Open-Label, Parallel-Group Study to Assess the Pharmacokinetics of Inclisiran in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function (ORION-7)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- The Medicines Company · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and severe renal impairment compared to participants with normal renal function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inclisiran | Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand. |
Timeline
- Start date
- 2017-06-22
- Primary completion
- 2018-03-24
- Completion
- 2018-03-24
- First posted
- 2017-05-18
- Last updated
- 2018-11-09
Locations
2 sites across 1 country: New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03159416. Inclusion in this directory is not an endorsement.