NCT03177395 (POP) is a Phase 1 clinical trial of PP100-01 (calmangafodipir) in Paracetamol Overdose, sponsored by Egetis Therapeutics.

Who is sponsoring NCT03177395?

NCT03177395 is sponsored by Egetis Therapeutics.

What drugs are being tested in NCT03177395?

Interventions in NCT03177395: PP100-01 (calmangafodipir), Acetylcysteine.

What condition does NCT03177395 study?

NCT03177395 studies Paracetamol Overdose.

Is NCT03177395 still recruiting?

NCT03177395 is currently completed. Last updated 3 October 2019.

Are results published for NCT03177395?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-03 · How we verify

NCT03177395: POP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PP100-01 (Calmangafodipir) for Overdose of Paracetamol

Completed Phase 1 Results posted Last updated 3 October 2019

What this trial tests

Phase 1 trial testing PP100-01 (calmangafodipir) in Paracetamol Overdose in 24 participants. Completed in 8 November 2018.

Timeline

8 June 2017

Primary endpoint
8 August 2018

8 November 2018

Quick facts

Lead sponsor	Egetis Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	8 June 2017
Primary completion	8 August 2018
Estimated completion	8 November 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

PP100-01 (calmangafodipir) — full drug profile →
Acetylcysteine (Acetylcysteine) — full drug profile →

Conditions studied

Paracetamol Overdose — all drugs for Paracetamol Overdose →

Sponsor

Egetis Therapeutics — full company profile →

Who can join

16 and older, any sex, with Paracetamol Overdose. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety Events Primary · 90 days

Adverse Events and Serious Adverse Events

Any Adverse event

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	6
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	6
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	6
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	6

Any serious adverse event

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	2
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	4
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	2
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	3

Adverse event after commencement of NAC treatment

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	6
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	5
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	6
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	6

Serious AE after commencement of NAC treatment

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	1
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	1
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	1
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	2

Adverse event where outcome was death

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	0
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	0
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	1
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	0

Adverse event unrelated to NAC

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	3
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	5
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	3
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	5

Adverse event possibly related to NAC

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	2
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	2
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	2
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	2

Adverse event probably related to NAC

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	3
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	2
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	3
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	2

ALT(U/L) Secondary · Baseline

The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	42.5	± 3.6
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	24.6	± 2.1
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	29.4	± 2.3
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	17.7	± 1.5

ALT(U/L) Secondary · 10 hours

The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	41.4	± 3.3
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	22.9	± 1.8
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	25.3	± 2.1
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	15.0	± 1.3

ALT(U/L) Secondary · 20 hours

The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	43.3	± 3.8
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	20.4	± 1.9
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	25.4	± 1.8
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	16.4	± 1.5

INR Secondary · Baseline

international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	1.02	± 0.04
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	1.00	± 0.12
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	0.98	± 0.04
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	1.05	± 0.14

INR Secondary · 10 hours

international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	1.30	± 0.18
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	1.17	± 0.20
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	1.20	± 0.00
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	1.22	± 0.25

INR Secondary · 20 hours

international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	1.18	± 0.21
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	1.07	± 0.19
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	1.08	± 0.04
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	1.22	± 1.17

INR Secondary · value at 20 hours divided by baseline value for each patient

international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	1.15	± 1.17
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	1.07	± 1.12
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	1.10	± 1.07
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	1.10	± 1.10

Additional NAC Infusion Secondary · Additional NAC at 12 hour

participants required additional NAC infusions after the 12-hour NAC regimen

None

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	3
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	5
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	6
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	6

One

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	1
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	1
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	0
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	0

Two

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	2
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	0
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	0
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	0

K18 (U/L) Secondary · Baseline (2 hours)

In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	187	± 2.20
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	177	± 1.82
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	193	± 1.56
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	128	± 1.25

K18(U/L) Secondary · 10 hours

In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	182	± 1.95
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	152	± 1.56
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	170	± 1.42
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	111	± 1.18

K18 (U/L) Secondary · 20 hours

In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.

Group	Value	95% CI
Acetylcysteine (N-acetylcysteine; NAC)	347	± 3.18
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC	229	± 1.94
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC	172	± 1.45
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC	181	± 1.73

Adverse events — posted to ClinicalTrials.gov

Time frame: 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. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acetylcysteine (N-acetylcysteine; NAC)

Serious: 2/6 (33%)

Deaths: 0/6

Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC

Serious: 4/6 (67%)

Deaths: 0/6

Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC

Serious: 2/6 (33%)

Deaths: 1/6

Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC

Serious: 3/6 (50%)

Deaths: 0/6

Serious adverse events (7 terms)

Reaction	System	Acetylcysteine (N-acetylcy…	Group A: PP100-01 (Calmang…	Group B: PP100-01 (Calmang…	Group C: PP100-01 (Calmang…
Gastrointestinal disorders	Gastrointestinal disorders	—	—	—	—
Infections and infestations	Infections and infestations	—	—	—	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—	—	—	—
Psychiatric disorders	Psychiatric disorders	—	—	—	—
cardiac disorders	Cardiac disorders	—	—	—	—
Nervous system disorders	Nervous system disorders	—	—	—	—
Vascular disorders	Vascular disorders	—	—	—	—

Other adverse events (33 terms — click to expand)

Reaction	System	Acetylcysteine (N-acetylcy…	Group A: PP100-01 (Calmang…	Group B: PP100-01 (Calmang…	Group C: PP100-01 (Calmang…
vomiting	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
abdominal pain	Gastrointestinal disorders	—	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Otitis externa	Infections and infestations	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Alcohol withdrawal syndrome	Psychiatric disorders	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
heart block	Cardiac disorders	—	—	—	—
Retching	Gastrointestinal disorders	—	—	—	—
Hypoaethesia oral	Gastrointestinal disorders	—	—	—	—
chest pain	General disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Tubo-ovarian abscess	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—
Soft tissue injury	Injury, poisoning and procedural complications	—	—	—	—
ntentional product misuse	Injury, poisoning and procedural complications	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
migraine	Nervous system disorders	—	—	—	—
substance abuse	Psychiatric disorders	—	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Most-reported serious reactions: Gastrointestinal disorders, Infections and infestations, Injury, poisoning and procedural complications, Psychiatric disorders, cardiac disorders, Nervous system disorders, Vascular disorders.

Data from ClinicalTrials.gov NCT03177395 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Risk stratification after paracetamol overdose using mechanistic biomarkers: results from two prospective cohort studies.
Dear JW, Clarke JI, Francis B, Allen L, et al · · 2018 · cited 89× · PMID 29146439 · DOI 10.1016/s2468-1253(17)30266-2
Chemotherapy-induced peripheral neuropathy-part 2: focus on the prevention of oxaliplatin-induced neurotoxicity.
Sałat K. · · 2020 · cited 73× · PMID 32347537 · DOI 10.1007/s43440-020-00106-1
Are some people at increased risk of paracetamol-induced liver injury? A critical review of the literature.
Caparrotta TM, Antoine DJ, Dear JW. · · 2018 · cited 49× · PMID 29067481 · DOI 10.1007/s00228-017-2356-6
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).
Morrison EE, Oatey K, Gallagher B, Grahamslaw J, et al · · 2019 · cited 37× · PMID 31311721 · DOI 10.1016/j.ebiom.2019.07.013
Restoring cellular magnesium balance through Cyclin M4 protects against acetaminophen-induced liver damage.
González-Recio I, Simón J, Goikoetxea-Usandizaga N, Serrano-Maciá M, et al · · 2022 · cited 26× · PMID 36433951 · DOI 10.1038/s41467-022-34262-0
Acetylcysteine in paracetamol poisoning: a perspective of 45 years of use.
Bateman DN, Dear JW. · · 2019 · cited 25× · PMID 31341611 · DOI 10.1039/c9tx00002j
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.
POP Trial Investigators, Dear J. · · 2019 · cited 8× · PMID 30621764 · DOI 10.1186/s13063-018-3134-1

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03177395 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Egetis Therapeutics
Last refreshed: 3 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03177395.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03177395: POP

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (7 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Egetis Therapeutics trials

Verify against primary sources