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

Hyperammonemia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hyperammonemia

Clinical Trial Details

NCT number	NCT06178718
Study type	Interventional
Source	TenNor Therapeutics Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	June 6, 2016
Completion date	July 30, 2016

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05842837` - A Non-Interventional Post-Authorization Study of Carbaglu for the Treatment of Hyperammonemia Due to MMA and PA
Terminated	`NCT05349435` - A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate	Phase 1
Completed	`NCT03947034` - Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Recruiting	`NCT05040178` - An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
Withdrawn	`NCT00279851` - Blood Sugars in Children With Idiopathic Seizures.
Completed	`NCT06135675` - Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia	Phase 1/Phase 2