Trial Outcomes & Findings for PP100-01 (Calmangafodipir) for Overdose of Paracetamol (NCT NCT03177395)
NCT ID: NCT03177395
Last Updated: 2019-10-03
Results Overview
Adverse Events and Serious Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
90 days
Results posted on
2019-10-03
Participant Flow
Studied period: 05 June 2017 to 08 August 2018 Study centres: Edinburgh Clinical Trials Unit (ECTU) The Emergency Medicine Research Group Edinburgh (EMERGE)
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
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Baseline characteristics by cohort
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
42.5 years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
42.7 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
22.7 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 13.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
24 participants
n=31 Participants
|
|
Time from ingestion of paracetamol to hospital presentation
|
8.8 hours
STANDARD_DEVIATION 6.2 • n=99 Participants
|
6.0 hours
STANDARD_DEVIATION 6.2 • n=107 Participants
|
5.8 hours
STANDARD_DEVIATION 7.2 • n=206 Participants
|
4.9 hours
STANDARD_DEVIATION 5.2 • n=7 Participants
|
6.4 hours
STANDARD_DEVIATION 6.2 • n=31 Participants
|
|
Type of overdose
Acute, ≤8 h to NAC
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Type of overdose
Acute, >8 h to NAC
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Type of overdose
Staggered intentional
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Type of overdose
Supra-therapeutic
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Presentation paracetamol concentration
|
76 mg/L
STANDARD_DEVIATION 81 • n=99 Participants
|
127 mg/L
STANDARD_DEVIATION 90 • n=107 Participants
|
74 mg/L
STANDARD_DEVIATION 44 • n=206 Participants
|
127 mg/L
STANDARD_DEVIATION 47 • n=7 Participants
|
101 mg/L
STANDARD_DEVIATION 66 • n=31 Participants
|
|
Total paracetamol ingested
|
185 mg/kg
STANDARD_DEVIATION 156 • n=99 Participants
|
235 mg/kg
STANDARD_DEVIATION 77 • n=107 Participants
|
229 mg/kg
STANDARD_DEVIATION 72 • n=206 Participants
|
397 mg/kg
STANDARD_DEVIATION 476 • n=7 Participants
|
262 mg/kg
STANDARD_DEVIATION 195 • n=31 Participants
|
|
Time from ingestion of paracetamol to start of NAC treatment
|
12.1 hours
STANDARD_DEVIATION 5.2 • n=99 Participants
|
9.8 hours
STANDARD_DEVIATION 6.5 • n=107 Participants
|
10.2 hours
STANDARD_DEVIATION 6.9 • n=206 Participants
|
8.6 hours
STANDARD_DEVIATION 4.1 • n=7 Participants
|
10.2 hours
STANDARD_DEVIATION 5.7 • n=31 Participants
|
|
Time from ingestion of paracetamol to start of calmangafodipir
|
NA hours
STANDARD_DEVIATION NA • n=99 Participants
|
12.6 hours
STANDARD_DEVIATION 6.8 • n=107 Participants
|
10.8 hours
STANDARD_DEVIATION 4.1 • n=206 Participants
|
11.8 hours
STANDARD_DEVIATION 5.4 • n=7 Participants
|
11.7 hours
STANDARD_DEVIATION 5.4 • n=31 Participants
|
|
Any other drug ingested
Yes
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Any other drug ingested
No
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Serum creatinine
|
74.7 μmol/L
STANDARD_DEVIATION 11.0 • n=99 Participants
|
67.5 μmol/L
STANDARD_DEVIATION 13.3 • n=107 Participants
|
67.3 μmol/L
STANDARD_DEVIATION 17.2 • n=206 Participants
|
69.5 μmol/L
STANDARD_DEVIATION 13.1 • n=7 Participants
|
69.8 μmol/L
STANDARD_DEVIATION 13.6 • n=31 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 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
Adverse Events and Serious Adverse Events
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
Safety Events
Any Adverse event
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
|
Safety Events
Any serious adverse event
|
2 participants
|
4 participants
|
2 participants
|
3 participants
|
|
Safety Events
Adverse event after commencement of NAC treatment
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
|
Safety Events
Serious AE after commencement of NAC treatment
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Safety Events
Adverse event where outcome was death
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety Events
Adverse event unrelated to NAC
|
3 participants
|
5 participants
|
3 participants
|
5 participants
|
|
Safety Events
Adverse event possibly related to NAC
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Safety Events
Adverse event probably related to NAC
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Safety Events
Adverse event definitely related to NAC
|
2 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Safety Events
Adverse event unrelated to PP100-01
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
|
Safety Events
Adverse event possibly related to PP100-01
|
0 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Safety Events
Adverse event probably related to PP100-01
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Events
Adverse event definitely related to PP100-01
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Events
Any suspected unexpected serious adverse reaction
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety Events
SUSAR to NAC
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Events
SUSAR to PP100-01
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety Events
SUSAR to NAC and PP100-01
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineThe alanine aminotransferase (ALT) test is a blood test that checks for liver damage.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ALT(U/L)
|
42.5 U/L
Standard Deviation 3.6
|
24.6 U/L
Standard Deviation 2.1
|
29.4 U/L
Standard Deviation 2.3
|
17.7 U/L
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 10 hoursPopulation: 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
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ALT(U/L)
|
41.4 U/L
Standard Deviation 3.3
|
22.9 U/L
Standard Deviation 1.8
|
25.3 U/L
Standard Deviation 2.1
|
15.0 U/L
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 20 hoursPopulation: 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
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ALT(U/L)
|
43.3 U/L
Standard Deviation 3.8
|
20.4 U/L
Standard Deviation 1.9
|
25.4 U/L
Standard Deviation 1.8
|
16.4 U/L
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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
international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=5 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
INR
|
1.02 ratio
Standard Deviation 0.04
|
1.00 ratio
Standard Deviation 0.12
|
0.98 ratio
Standard Deviation 0.04
|
1.05 ratio
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 10 hoursinternational normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
INR
|
1.30 ratio
Standard Deviation 0.18
|
1.17 ratio
Standard Deviation 0.20
|
1.20 ratio
Standard Deviation 0.00
|
1.22 ratio
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 20 hoursinternational normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
INR
|
1.18 ratio
Standard Deviation 0.21
|
1.07 ratio
Standard Deviation 0.19
|
1.08 ratio
Standard Deviation 0.04
|
1.22 ratio
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: value at 20 hours divided by baseline value for each patientinternational normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=5 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
INR
|
1.15 ratio
Standard Deviation 1.17
|
1.07 ratio
Standard Deviation 1.12
|
1.10 ratio
Standard Deviation 1.07
|
1.10 ratio
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Additional NAC at 12 hourparticipants required additional NAC infusions after the 12-hour NAC regimen
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
Additional NAC Infusion
None
|
3 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Additional NAC Infusion
One
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Additional NAC Infusion
Two
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (2 hours)In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
K18 (U/L)
|
187 U/L
Standard Deviation 2.20
|
177 U/L
Standard Deviation 1.82
|
193 U/L
Standard Deviation 1.56
|
128 U/L
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: 10 hoursIn paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
K18(U/L)
|
182 U/L
Standard Deviation 1.95
|
152 U/L
Standard Deviation 1.56
|
170 U/L
Standard Deviation 1.42
|
111 U/L
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 20 hoursIn paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
K18 (U/L)
|
347 U/L
Standard Deviation 3.18
|
229 U/L
Standard Deviation 1.94
|
172 U/L
Standard Deviation 1.45
|
181 U/L
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Ratio - value at 20 hours divided by baseline value for each patientIn paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
K18 (U/L)
|
1.85 U/L
Standard Deviation 1.47
|
1.29 U/L
Standard Deviation 1.89
|
0.89 U/L
Standard Deviation 1.57
|
1.41 U/L
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Baseline (2 hours)The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ccK18 (U/L)
|
67 U/L
Standard Deviation 1.99
|
45 U/L
Standard Deviation 1.33
|
84 U/L
Standard Deviation 1.80
|
104 U/L
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: 10 hoursThe shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ccK18 (U/L)
|
72 U/L
Standard Deviation 2.24
|
53 U/L
Standard Deviation 1.25
|
56 U/L
Standard Deviation 1.57
|
78 U/L
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: 20 hoursThe shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ccK18 (U/L)
|
149 U/L
Standard Deviation 3.34
|
66 U/L
Standard Deviation 1.34
|
85 U/L
Standard Deviation 1.62
|
111 U/L
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Ratio - value at 20 hours divided by baseline value for each patientCaspace-cleaved Keratin-18
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
ccK18 (U/L)
|
2.22 U/L
Standard Deviation 1.77
|
1.49 U/L
Standard Deviation 1.55
|
1.02 U/L
Standard Deviation 1.79
|
1.08 U/L
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: Baseline (2 hours)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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122 (Delta Count)
|
5.58 DCt
Standard Deviation 3.36
|
5.85 DCt
Standard Deviation 1.50
|
4.43 DCt
Standard Deviation 3.92
|
8.73 DCt
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: 10 hoursMiR-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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122 (Delta Count)
|
5.41 DCt
Standard Deviation 3.86
|
6.14 DCt
Standard Deviation 1.99
|
5.01 DCt
Standard Deviation 3.36
|
9.00 DCt
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: 20 hoursMiR-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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122 (Delta Count)
|
4.85 DCt
Standard Deviation 3.97
|
7.12 DCt
Standard Deviation 2.26
|
4.49 DCt
Standard Deviation 2.93
|
8.44 DCt
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline (2 h)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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122 (Copies/mcL)
|
146,363 copies/mcL
Standard Deviation 11.7
|
116,749 copies/mcL
Standard Deviation 2.4
|
194,075 copies/mcL
Standard Deviation 13.5
|
36,051 copies/mcL
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 10 hoursMiR-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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122(Copies/mcL)
|
206,205 copies/mcL
Standard Deviation 13.0
|
109,882 copies/mcL
Standard Deviation 3.3
|
196,732 copies/mcL
Standard Deviation 9.4
|
37,066 copies/mcL
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 20 hoursMiR-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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122 (Copies/mcL)
|
216,256 copies/mcL
Standard Deviation 10.8
|
57,664 copies/mcL
Standard Deviation 3.8
|
202,271 copies/mcL
Standard Deviation 7.7
|
40,745 copies/mcL
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Ratio - value at 20 hours divided by baseline value for each patientMiR-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
Outcome measures
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 Participants
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 Participants
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 Participants
In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive:
* Group A: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC
* Group C: 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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 Participants
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
|
|---|---|---|---|---|
|
miR-122 (Copies/mcL)
|
1.48 copies/mcL
Standard Deviation 5.71
|
0.49 copies/mcL
Standard Deviation 1.98
|
1.04 copies/mcL
Standard Deviation 8.28
|
1.13 copies/mcL
Standard Deviation 2.96
|
Adverse Events
Acetylcysteine (N-acetylcysteine; NAC)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 participants at risk
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 participants at risk
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 participants at risk
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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 participants at risk
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
|
|---|---|---|---|---|
|
Cardiac disorders
cardiac disorders
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Psychiatric disorders
Psychiatric disorders
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
Other adverse events
| Measure |
Acetylcysteine (N-acetylcysteine; NAC)
n=6 participants at risk
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.
|
Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC
n=6 participants at risk
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
|
Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC
n=6 participants at risk
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
|
Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC
n=6 participants at risk
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
|
|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Cardiac disorders
Ventricular extrasystoles
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
50.0%
3/6 • Number of events 3 • 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
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Injury, poisoning and procedural complications
Overdose
|
16.7%
1/6 • Number of events 1 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
16.7%
1/6 • Number of events 2 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Cardiac disorders
heart block
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
vomiting
|
66.7%
4/6 • Number of events 4 • 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
|
66.7%
4/6 • Number of events 7 • 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
|
33.3%
2/6 • Number of events 2 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Gastrointestinal disorders
abdominal pain
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
50.0%
3/6 • Number of events 3 • 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
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Gastrointestinal disorders
Hypoaethesia oral
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
General disorders
chest pain
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
ntentional product misuse
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 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
|
33.3%
2/6 • Number of events 3 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
16.7%
1/6 • Number of events 2 • 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
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Nervous system disorders
migraine
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
|
Psychiatric disorders
substance abuse
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
16.7%
1/6 • Number of events 1 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
0.00%
0/6 • 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
|
Additional Information
Dr James Dear
Pharmacology, Therapeutics and Toxicology Unit, Centre for Cardiovascular Science, University of Edinburgh, UK
Phone: +44(0)131 242 9214
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place