Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891158
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-05-26
Brief Title:
A Study About Fazirsiran in People With and Without Liver Problems
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503735-17 | OTHER | EU CTIS | None |