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PP100-01 (Calmangafodipir) for Overdose of Paracetamol

2017-06-06 20:38:21 | BioPortfolio

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.

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.

Study Design

Conditions

Paracetamol Overdose

Intervention

PP100-01 (calmangafodipir)

Location

Royal Infirmary of Edinburgh
Edinburgh
City of Edinburgh
United Kingdom
EH16 4SA

Status

Not yet recruiting

Source

PledPharma AB

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-06T20:38:21-0400

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