Study of TYNADOTE Combined With N-acetylcysteine for Treating Acetaminophen Overdose in Adults

What this Trial Is About

The trial investigates the efficacy and safety of TYNADOTE4 combined with intravenous N-acetylcysteine NAC for treating acetaminophen overdose. The study focuses on patients poisoned by acetaminophen who meet specific ingestion or plasma concentration criteria. This Phase 2 study aims to assess liver function and injury markers to understand TYNADOTE4s potential impact when added to standard NAC therapy. Participants will be randomly assigned in a 11 ratio to receive either oral TYNADOTE4 or a matching placebo alongside the standard NAC intravenous regimen. The NAC treatment includes a loading dose followed by two maintenance infusions over 20 hours. TYNADOTE4 or placebo is given with a 400 mg loading dose followed by 17 doses of 200 mg every 4 hours from Day 1 to Day 3. During the 21-day study, participants will have frequent vital sign checks and blood tests to monitor liver enzymes, bilirubin, coagulation, and drug concentrations at multiple time points before and after dosing. Safety assessments, adverse event reviews, physical exams, and follow-ups occur through Day 21. The primary outcome is alanine aminotransferase ALT levels at Day 3, with several secondary outcomes covering liver function, hepatic failure, mortality, and drug metabolite levels.

To Evaluate the Efficacy and Safety of TYNADOTE® in the Treatment of Acetaminophen Overdose