Trials / Completed
CompletedNCT05891158
A Study About Fazirsiran in People With and Without Liver Problems
An Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics in Response to a Single Subcutaneous Dose of Fazirsiran (TAK-999) in Subjects With or Without Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
The main aim of this study is to learn how the body processes fazirsiran (pharmacokinetics \[PK\]) in people with mild, moderate, or severe liver problems, compared to people with normal liver function. The study will include participants with liver scarring (cirrhosis) and mild, moderate, or severe liver problems, and participants with normal liver function. All participants will be given 1 injection of fazirsiran and will be followed up for 6 months after the fazirsiran injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fazirsiran | Fazirsiran SC injection |
Timeline
- Start date
- 2023-10-05
- Primary completion
- 2025-09-03
- Completion
- 2025-09-03
- First posted
- 2023-06-06
- Last updated
- 2026-03-19
Locations
4 sites across 2 countries: Hungary, Slovakia
Source: ClinicalTrials.gov record NCT05891158. Inclusion in this directory is not an endorsement.