Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178718
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2023-12-07
Brief Title:
A Phase 1 Single-center Double-blind Placebo-controlled Study of TNP-2092 Capsules and the Food Effect Study After Single-dose Oral Administration of TNP-2092 Capsules
Sponsor:
TenNor Therapeutics Suzhou Limited
Organization:
TenNor Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Single-center Double-blind Placebo-controlled Clinical Study to Evaluate the Safety Tolerability and Pharmacokinetics of TNP-2092 Capsules and the Food Effect on the Pharmacokinetics of TNP-2092 Capsules After Single-dose Oral Administration in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-12
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 aim of this study is to evaluate the safety tolerability and pharmacokinetic characteristics of TNP-2092 Capsules in liver cirrhosis patients with hyperammonemia and to preliminarily observe the effects of the study drug on blood ammonia and hepatic encephalopathy related clinical symptoms and signs neuropsychological indicators and quality of life in liver cirrhosis patients with hyperammonemia
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?:
False
Is an FDA AA801 Violation?:
None