PP100-01 (Calmangafodipir) for Overdose of Paracetamol — POP  

Paracetamol Overdose Clinical Trial

Official title: A Randomised Open Label Exploratory, Safety and Tolerability Study With PP100-01 in Patients Treated With the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose (The POP Trial)

Status Completed

Clinical Trial Summary

Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC treatment is initiated before 24hours post POD.

Clinical Trial Description

The study will be an open label, randomised, exploratory, rising dose design, NAC controlled, phase 1 safety and tolerability study in patients treated with NAC for paracetamol/acetaminophen overdose.

Entry into the study will depend on the patient's blood results confirming the need for NAC. A total of 24 patients will be assigned into one of 3 dosing cohorts of 8 patients (N=6 for PP100-01 and NAC; N=2 for NAC alone).

The study will primarily evaluate safety and tolerability for treatment with PP100-01 in combination with NAC as compared to NAC alone. ;

Related Conditions & MeSH terms

• Drug Overdose
• Paracetamol Overdose

• NCT number: NCT03177395
• Study type: Interventional
• Source: PledPharma AB
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2017
• Completion date: November 8, 2018