NCT03177395

PP100-01 (Calmangafodipir) for Overdose of Paracetamol

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Egetis Therapeutics · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Paracetamol Overdose

Interventions

Type	Name	Description
DRUG	PP100-01 (calmangafodipir)	PP100-01
DRUG	Acetylcysteine	NAC

Timeline

• Start date: 2017-06-08
• Primary completion: 2018-08-08
• Completion: 2018-11-08
• First posted: 2017-06-06
• Last updated: 2019-10-03
• Results posted: 2019-10-03

Locations

1 site across 1 country: United Kingdom