Trial Outcomes & Findings for A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects (NCT NCT01339897)
NCT ID: NCT01339897
Last Updated: 2015-01-19
Results Overview
Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Over 7 days
Results posted on
2015-01-19
Participant Flow
Recruitment occurred between 06April2011 and 09August2011. This study was done at a single Phase 1 site.
Participant milestones
| Measure |
5 mg/N6022
Active Group- 5 mg by IV administration (5 mg/minute)
|
Placebo
Non-Active
|
10 mg/N6022
Active Group- 10 mg by IV administration (5 mg/minute)
|
20 mg/N6022
Active Group- 20 mg by IV administration (5 mg/minute)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
5 mg/N6022
Active Group- 5 mg by IV administration (5 mg/minute)
|
Placebo
Non-Active
|
10 mg/N6022
Active Group- 10 mg by IV administration (5 mg/minute)
|
20 mg/N6022
Active Group- 20 mg by IV administration (5 mg/minute)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1
n=7 Participants
N6022 - Active 5 mg
|
Cohort 2
n=6 Participants
N6022 - Active 10 mg
|
Cohort 3
n=6 Participants
N6022 - Active 20 mg
|
Placebo
n=6 Participants
Non-Active
|
Total
n=25 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 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
|
|
Age, Continuous
|
32 years
n=5 Participants
|
31 years
n=7 Participants
|
35 years
n=5 Participants
|
35 years
n=4 Participants
|
33 years
n=21 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
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Over 7 daysPopulation: Any subject that received any dose of N6022 or placebo.
Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)
Outcome measures
| Measure |
Cohort 1
n=7 Participants
N6022 - Active 5 mg
|
Cohort 2
n=6 Participants
N6022 Active - 10 mg
|
Cohort 3
n=6 Participants
N6022 - Active 20 mg
|
Placebo
n=6 Participants
Non-Active
|
|---|---|---|---|---|
|
Safety of Escalating Multiple Doses of N6022 in Healthy Subjects
Number of subjects on study
|
7 participants
|
6 participants
|
6 participants
|
6 participants
|
|
Safety of Escalating Multiple Doses of N6022 in Healthy Subjects
Early Termination
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety of Escalating Multiple Doses of N6022 in Healthy Subjects
Treatment related AE
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1, 24 hoursPopulation: Any subject that completed N6022 or placebo PK sampling
N6022 AUC0-tau measurements from Day 1
Outcome measures
| Measure |
Cohort 1
n=7 Participants
N6022 - Active 5 mg
|
Cohort 2
n=6 Participants
N6022 Active - 10 mg
|
Cohort 3
n=6 Participants
N6022 - Active 20 mg
|
Placebo
n=6 Participants
Non-Active
|
|---|---|---|---|---|
|
Pharmacokinetics of N6022
|
138 h*ng/mL
Geometric Coefficient of Variation 13.0
|
334 h*ng/mL
Geometric Coefficient of Variation 21.1
|
669 h*ng/mL
Geometric Coefficient of Variation 16.9
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Day 7, 24 hoursPopulation: N6022 AUC0-tau values from Study Day 7
Analysis of N6022 AUC0-tau values from Study Day 7
Outcome measures
| Measure |
Cohort 1
n=6 Participants
N6022 - Active 5 mg
|
Cohort 2
n=6 Participants
N6022 Active - 10 mg
|
Cohort 3
n=5 Participants
N6022 - Active 20 mg
|
Placebo
n=6 Participants
Non-Active
|
|---|---|---|---|---|
|
Pharmacokinetics of N6022 Over 7 Days
|
149 h*ng/mL
Geometric Coefficient of Variation 24.6
|
367 h*ng/mL
Geometric Coefficient of Variation 14.2
|
811 h*ng/mL
Geometric Coefficient of Variation 11.3
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Day 1, 24 hoursAnalysis of N6022 Cmax values on Study Day 1
Outcome measures
| Measure |
Cohort 1
n=7 Participants
N6022 - Active 5 mg
|
Cohort 2
n=6 Participants
N6022 Active - 10 mg
|
Cohort 3
n=6 Participants
N6022 - Active 20 mg
|
Placebo
n=6 Participants
Non-Active
|
|---|---|---|---|---|
|
Pharmacokinetics of N6022 on Study Day 1
|
465 ng/mL
Geometric Coefficient of Variation 69.8
|
1270 ng/mL
Geometric Coefficient of Variation 95.6
|
1400 ng/mL
Geometric Coefficient of Variation 86.2
|
0 ng/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Day 7, 24 hoursPharmacokinetic Analysis of N6022 Cmax values on Study Day 7
Outcome measures
| Measure |
Cohort 1
n=6 Participants
N6022 - Active 5 mg
|
Cohort 2
n=6 Participants
N6022 Active - 10 mg
|
Cohort 3
n=5 Participants
N6022 - Active 20 mg
|
Placebo
n=6 Participants
Non-Active
|
|---|---|---|---|---|
|
Pharmacokinetics of N6022 Cmax Values on Study Day 7
|
287 ng/mL
Geometric Coefficient of Variation 89.8
|
1110 ng/mL
Geometric Coefficient of Variation 34.1
|
2320 ng/mL
Geometric Coefficient of Variation 13.5
|
0 ng/mL
Geometric Coefficient of Variation 0
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=7 participants at risk
N6022 - Active 5 mg
|
Cohort 2
n=6 participants at risk
N6022 Active - 10 mg
|
Cohort 3
n=6 participants at risk
N6022 - Active 20 mg
|
Placebo
n=6 participants at risk
Non-Active
|
|---|---|---|---|---|
|
Cardiac disorders
Ventricular Arrythmia
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
General disorders
Injection Site Extravasation
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Infections and infestations
Otitis Externa
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Musculoskeletal and connective tissue disorders
Musculosketetal Pain
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
14.3%
1/7 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
General disorders
Vessel Puncture Site Hematoma
|
0.00%
0/7 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Infections and infestations
Upper Respiratory tract Infection
|
0.00%
0/7 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Injury, poisoning and procedural complications
Traumatic Hematoma
|
0.00%
0/7 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Investigations
Blood Magnesium Abnormal
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Nervous system disorders
Pre-syncope
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
0.00%
0/6 • 7 Days
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
|
General disorders
Injection Site Induration
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
|
General disorders
Injection Site Pain
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
33.3%
2/6 • Number of events 2 • 7 Days
|
|
Vascular disorders
Phlebitis Superficial
|
0.00%
0/7 • 7 Days
|
0.00%
0/6 • 7 Days
|
0.00%
0/6 • 7 Days
|
16.7%
1/6 • Number of events 1 • 7 Days
|
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