Trial Outcomes & Findings for Safety and Tolerability Study of N6022 in Healthy Subjects (NCT NCT01147406)
NCT ID: NCT01147406
Last Updated: 2014-03-07
Results Overview
Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
7 Days
Results posted on
2014-03-07
Participant Flow
Participant milestones
| Measure |
Cohort 1
5 mg of N6022 was given intravenously daily for 7 days
|
Cohorts 2 and 4
15 mg of N6022 was given intravenously daily for 7 days
|
Cohort 3
45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg.
|
Cohort 5
25 mg of N6022 was given intravenously daily for 7 days
|
Cohort 6
35 mg of N6022 was given intravenously daily for 7 days
|
Placebo
Not Active - Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
1
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
12
|
1
|
6
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability Study of N6022 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
N6022 - Active 5 mg
|
Cohort 2 & 4
n=12 Participants
N6022 - Active 15 mg
|
Cohort 3
n=1 Participants
N6022 - Active 45 mg (actual \*27.5 mg)
|
Cohort 5
n=6 Participants
N6022 - Active 25 mg
|
Cohort 6
n=6 Participants
N6022 - Active 35 mg
|
Placebo
n=10 Participants
Not Active - Placebo
|
Total
n=41 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
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Age, Categorical
>=65 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
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
10 participants
n=10 Participants
|
41 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 7 DaysPopulation: Any subject that received active IMP or placebo
Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
N6022 - Active 5 mg
|
Cohort 2 and 4
n=12 Participants
N6022 - Active 15 mg
|
Cohort 3
n=1 Participants
N6022 - Active 45 mg
|
Cohort 5
n=6 Participants
N6022 - Active 25 mg
|
Cohort 6
n=6 Participants
N6022 - Active 35 mg
|
Placebo
n=10 Participants
Not Active - Placebo
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers
|
1 Adverse Events
|
4 Adverse Events
|
1 Adverse Events
|
0 Adverse Events
|
1 Adverse Events
|
2 Adverse Events
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Any subject that received the active IMP or placebo
Concentrations of N6022 and metabolite \[N61149)\], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).
Outcome measures
| Measure |
Cohort 1
n=6 Participants
N6022 - Active 5 mg
|
Cohort 2 and 4
n=12 Participants
N6022 - Active 15 mg
|
Cohort 3
n=1 Participants
N6022 - Active 45 mg
|
Cohort 5
n=6 Participants
N6022 - Active 25 mg
|
Cohort 6
n=6 Participants
N6022 - Active 35 mg
|
Placebo
n=10 Participants
Not Active - Placebo
|
|---|---|---|---|---|---|---|
|
Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration
|
311 ng/mL
Geometric Coefficient of Variation 86.6
|
1570 ng/mL
Geometric Coefficient of Variation 51.5
|
1590 ng/mL
Geometric Coefficient of Variation 0
|
3330 ng/mL
Geometric Coefficient of Variation 42.1
|
4030 ng/mL
Geometric Coefficient of Variation 55.3
|
0 ng/mL
Geometric Coefficient of Variation 0
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 and 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
N6022 - Active 5 mg
|
Cohort 2 and 4
n=12 participants at risk
N6022 - Active 15 mg
|
Cohort 3
n=1 participants at risk
N6022 - Active 45 mg
|
Cohort 5
n=6 participants at risk
N6022 - Active 25 mg
|
Cohort 6
n=6 participants at risk
N6022 - Active 35 mg
|
Placebo
n=6 participants at risk；n=10 participants at risk
Not Active - Placebo
|
|---|---|---|---|---|---|---|
|
General disorders
Injection Site Pain
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • 6 months and 2 weeks
|
8.3%
1/12 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 6 months and 2 weeks
|
8.3%
1/12 • Number of events 1 • 6 months and 2 weeks
|
100.0%
1/1 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
General disorders
Injection Site Hematoma
|
0.00%
0/6 • 6 months and 2 weeks
|
8.3%
1/12 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6 • 6 months and 2 weeks
|
8.3%
1/12 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
2/12 • Number of events 2 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 6 months and 2 weeks
|
8.3%
1/12 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
100.0%
1/1 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
100.0%
1/1 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
100.0%
1/1 • Number of events 1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/12 • 6 months and 2 weeks
|
0.00%
0/1 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
0.00%
0/6 • 6 months and 2 weeks
|
16.7%
1/6 • Number of events 1 • 6 months and 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees with the use of results of the clinical study for the purposes of national and international registration, publication, and information for medical and pharmaceutical professionals. If necessary, the competent authorities will be notified of the investigator's name, address, qualifications, and extent of involvement. An investigator shall not publish any data (poster, abstract, paper, etc.) without having consulted with the Sponsor in advance.
- Publication restrictions are in place
Restriction type: OTHER