Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336018
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-22
Brief Title:
A Research Study on Etavopivat in Participants With and Without Liver Disease
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Multi-centre Open-label Parallel-group Study Investigating the Pharmacokinetics Safety and Tolerability After a Single Dose of Oral Etavopivat in Participants With Mild Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function
Status:
RECRUITING
Status Verified Date:
2024-06
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 study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function matched controls During the study all participants will be given a single oral dose of etavopivat All participants will take the etavopivat orally together with water After dosing the study will last for 7 to 9 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| U1111-1289-2466 | OTHER | World Health Organization WHO | None |