Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery (NCT NCT01535222)
NCT ID: NCT01535222
Last Updated: 2012-07-19
Results Overview
Number of patients experiencing Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
7 days (day of surgery to day 7)
Results posted on
2012-07-19
Participant Flow
Participant milestones
| Measure |
Cohort 1
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
7
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
|---|---|---|---|---|---|---|
|
Overall Study
Inclusion/exclusion
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
n=3 Participants
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
n=7 Participants
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
n=6 Participants
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
n=6 Participants
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
n=8 Participants
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Age Continuous
|
63.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
62 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
59 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
68 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
63.2 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
65.9 years
STANDARD_DEVIATION 5.6 • n=10 Participants
|
63.9 years
STANDARD_DEVIATION 9.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
8 participants
n=10 Participants
|
33 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 7 days (day of surgery to day 7)Number of patients experiencing Adverse Events
Outcome measures
| Measure |
Cohort 1
n=3 Participants
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
n=3 Participants
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
n=6 Participants
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
n=6 Participants
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
n=6 Participants
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
n=8 Participants
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
|
3 participants
|
3 participants
|
5 participants
|
4 participants
|
6 participants
|
7 participants
|
PRIMARY outcome
Timeframe: 7 days (day of surgery to day 7)Number of patients experiencing Serious Adverse Events
Outcome measures
| Measure |
Cohort 1
n=3 Participants
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
n=3 Participants
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
n=6 Participants
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
n=6 Participants
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
n=6 Participants
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
n=8 Participants
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
|---|---|---|---|---|---|---|
|
Incidence of Serious Adverse Events
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
n=3 participants at risk
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
n=6 participants at risk
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
n=6 participants at risk
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
n=6 participants at risk
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
n=8 participants at risk
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
General disorders
Device leakage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
|
Cohort 2
n=3 participants at risk
loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
|
Cohort 3
n=6 participants at risk
loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
|
Cohort 4
n=6 participants at risk
loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
|
Cohort 5
n=6 participants at risk
loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
|
Placebo
n=8 participants at risk
commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Hemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
2/8 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chest pain
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
50.0%
4/8 • Number of events 4
|
|
Injury, poisoning and procedural complications
Post procedural MI
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Alanine aminotransferase (ALAT) increased
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Investigations
Aspartate aminotransferase (ASAT) increased
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/8
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
2/8 • Number of events 2
|
Additional Information
Results disclosure agreements
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Restriction type: OTHER