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| Name | Class |
|---|---|
| University of Edinburgh | OTHER |
| NHS Lothian | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylcysteine (N-acetylcysteine; NAC) | No Intervention | NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian. | |
| PP100-01 (Calmangafodipir)+ NAC | Experimental | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
PP100-01 treatment is administered intravenously over 5 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP100-01 (calmangafodipir) | Drug | PP100-01 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Events | Adverse Events and Serious Adverse Events | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| ALT(U/L) | The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. | Baseline |
| ALT(U/L) | The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Dear | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | City Of Edinburgh | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31311721 | Derived | Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13. | |
| 30621764 |
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Adults within 24 h of a paracetamol overdose that required NAC. Within each of 3 sequential cohorts, participants were randomly assigned, with concealed allocation, to NAC and a single intravenous calmangafodipir dose (n=6/dose) or NAC alone (n=2). Calmangafodipir doses were 2, 5, or 10 μmol/kg. Participants, study and clinical teams not blinded
Studied period: 05 June 2017 to 08 August 2018 Study centres: Edinburgh Clinical Trials Unit (ECTU) The Emergency Medicine Research Group Edinburgh (EMERGE)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acetylcysteine (N-acetylcysteine; NAC) | NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian. |
| FG001 | Group A: PP100-01 (Calmangafodipir 2 μmol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (2 μmol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. |
| FG002 | Group B: PP100-01 (Calmangafodipir 5 μmol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (5 μmol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. |
| FG003 | Group C: PP100-01 (Calmangafodipir 10 μmol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (10 μmol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 24 participants randomised to the study. All participants received the full dose of PP100-01 according to the allocated dosing cohort where randomised to PP100-01 treatment and all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). Total dose was adjusted according to participant weight
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetylcysteine (N-acetylcysteine; NAC) | NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian. |
| BG001 | Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Events | Adverse Events and Serious Adverse Events | In addition to paracetamol overdose, 19 out of the 24 randomised participants reported taking overdoses of other medicines in addition to the paracetamol. All treatment groups included participants with paracetamol only overdoses and mixed overdoses | Posted | Number | participants | 90 days |
|
Adverse events / adverse reactions were assessed at baseline, 2, 2.5, 10, 20 and 22 hours as well as ad hoc and as part of follow up. Following discharge, patients were followed up using their electronic records. AE data were collected 7, 30 and 90 days after randomisation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetylcysteine (N-acetylcysteine; NAC) | NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac disorders | Cardiac disorders | MedDRA | Systematic Assessment | Chest tightnes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Dear | Pharmacology, Therapeutics and Toxicology Unit, Centre for Cardiovascular Science, University of Edinburgh, UK | +44(0)131 242 9214 | james.dear@ed.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2017 | Sep 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2018 | Sep 10, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C060076 | N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Acetylcysteine | Drug | NAC |
|
|
| 10 hours |
| ALT(U/L) | The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. | 20 hours |
| INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | Baseline |
| INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | 10 hours |
| INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | 20 hours |
| INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | value at 20 hours divided by baseline value for each patient |
| Additional NAC Infusion | participants required additional NAC infusions after the 12-hour NAC regimen | Additional NAC at 12 hour |
| K18 (U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | Baseline (2 hours) |
| K18(U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | 10 hours |
| K18 (U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | 20 hours |
| K18 (U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | Ratio - value at 20 hours divided by baseline value for each patient |
| ccK18 (U/L) | The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). | Baseline (2 hours) |
| ccK18 (U/L) | The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). | 10 hours |
| ccK18 (U/L) | The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). | 20 hours |
| ccK18 (U/L) | Caspace-cleaved Keratin-18 | Ratio - value at 20 hours divided by baseline value for each patient |
| miR-122 (Delta Count) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Baseline (2 hours) |
| miR-122 (Delta Count) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | 10 hours |
| miR-122 (Delta Count) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | 20 hours |
| miR-122 (Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Baseline (2 h) |
| miR-122(Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | 10 hours |
| miR-122 (Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | 20 hours |
| miR-122 (Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Ratio - value at 20 hours divided by baseline value for each patient |
| Derived |
| POP Trial Investigators; Dear J. Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial. Trials. 2019 Jan 8;20(1):27. doi: 10.1186/s13063-018-3134-1. |
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 |
| BG002 | Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 |
| BG003 | Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: • Group B: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time from ingestion of paracetamol to hospital presentation | Mean | Standard Deviation | hours |
|
| Type of overdose | Count of Participants | Participants |
|
| Presentation paracetamol concentration | Mean | Standard Deviation | mg/L |
|
| Total paracetamol ingested | Mean | Standard Deviation | mg/kg |
|
| Time from ingestion of paracetamol to start of NAC treatment | Mean | Standard Deviation | hours |
|
| Time from ingestion of paracetamol to start of calmangafodipir | Mean | Standard Deviation | hours |
|
| Any other drug ingested | Count of Participants | Participants |
|
| Serum creatinine | Mean | Standard Deviation | μmol/L |
|
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC
PP100-01 treatment is administered intravenously over 5 minutes.
PP100-01 (calmangafodipir): PP100-01
| OG002 | Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 |
| OG003 | Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 |
|
|
| Secondary | ALT(U/L) | The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. | Posted | Geometric Mean | Standard Deviation | U/L | Baseline |
|
|
|
| Secondary | ALT(U/L) | The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. | All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight | Posted | Geometric Mean | Standard Deviation | U/L | 10 hours |
|
|
|
| Secondary | ALT(U/L) | The alanine aminotransferase (ALT) test is a blood test that checks for liver damage. | All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight | Posted | Geometric Mean | Standard Deviation | U/L | 20 hours |
|
|
|
| Secondary | INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight | Posted | Mean | Standard Deviation | ratio | Baseline |
|
|
|
| Secondary | INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | Posted | Mean | Standard Deviation | ratio | 10 hours |
|
|
|
| Secondary | INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | Posted | Mean | Standard Deviation | ratio | 20 hours |
|
|
|
| Secondary | INR | international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF) | Posted | Geometric Mean | Standard Deviation | ratio | value at 20 hours divided by baseline value for each patient |
|
|
|
| Secondary | Additional NAC Infusion | participants required additional NAC infusions after the 12-hour NAC regimen | Posted | Count of Participants | Participants | Additional NAC at 12 hour |
|
|
|
| Secondary | K18 (U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | Posted | Geometric Mean | Standard Deviation | U/L | Baseline (2 hours) |
|
|
|
| Secondary | K18(U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | Posted | Geometric Mean | Standard Deviation | U/L | 10 hours |
|
|
|
| Secondary | K18 (U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | Posted | Geometric Mean | Standard Deviation | U/L | 20 hours |
|
|
|
| Secondary | K18 (U/L) | In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death. | Posted | Geometric Mean | Standard Deviation | U/L | Ratio - value at 20 hours divided by baseline value for each patient |
|
|
|
| Secondary | ccK18 (U/L) | The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). | Posted | Geometric Mean | Standard Deviation | U/L | Baseline (2 hours) |
|
|
|
| Secondary | ccK18 (U/L) | The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). | Posted | Geometric Mean | Standard Deviation | U/L | 10 hours |
|
|
|
| Secondary | ccK18 (U/L) | The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death). | Posted | Geometric Mean | Standard Deviation | U/L | 20 hours |
|
|
|
| Secondary | ccK18 (U/L) | Caspace-cleaved Keratin-18 | Posted | Geometric Mean | Standard Deviation | U/L | Ratio - value at 20 hours divided by baseline value for each patient |
|
|
|
| Secondary | miR-122 (Delta Count) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Mean | Standard Deviation | DCt | Baseline (2 hours) |
|
|
|
| Secondary | miR-122 (Delta Count) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Mean | Standard Deviation | DCt | 10 hours |
|
|
|
| Secondary | miR-122 (Delta Count) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Mean | Standard Deviation | DCt | 20 hours |
|
|
|
| Secondary | miR-122 (Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Geometric Mean | Standard Deviation | copies/mcL | Baseline (2 h) |
|
|
|
| Secondary | miR-122(Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Geometric Mean | Standard Deviation | copies/mcL | 10 hours |
|
|
|
| Secondary | miR-122 (Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Geometric Mean | Standard Deviation | copies/mcL | 20 hours |
|
|
|
| Secondary | miR-122 (Copies/mcL) | MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose | Posted | Geometric Mean | Standard Deviation | copies/mcL | Ratio - value at 20 hours divided by baseline value for each patient |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 | 0 | 6 | 4 | 6 | 6 | 6 |
| EG002 | Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 | 1 | 6 | 2 | 6 | 6 | 6 |
| EG003 | Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 | 0 | 6 | 3 | 6 | 6 | 6 |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA | Systematic Assessment | Nausea, vomiting |
|
| Infections and infestations | Infections and infestations | MedDRA | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA | Systematic Assessment | depressive episode;, mental health crisis;mental health issue (11006) |
|
| Vascular disorders | Vascular disorders | MedDRA | Systematic Assessment | seizures |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| heart block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hypoaethesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tubo-ovarian abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| ntentional product misuse | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| substance abuse | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| One |
|
| Two |
|