Trial Outcomes & Findings for Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (NCT NCT01746784)
NCT ID: NCT01746784
Last Updated: 2014-11-24
Results Overview
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
Over 7 treatment days and 7 days of follow-up
Results posted on
2014-11-24
Participant Flow
17 Clinical Investigator Sites enrolled 66 subjects. The first patient was screened on March 5, 2013 and the last patient was seen on April 10, 2014.
There were 4 ascending dose cohorts starting at 5 mg and continuing with 10 mg, 20 mg and 40 mg. There was a fifth confirmatory cohort at the maximum tested dose, 40 mg. In Cohorts 1-4 approximately 9 subjects received N6022 and 3 received placebo. In the fifth cohort 11 subjects received N6022 and 7 subjects receive placebo
Participant milestones
| Measure |
Placebo/Saline
0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
|
5 mg/N6022
N6022 was administered by intravenous infusion once per day for 7 days
|
10 mg/N6022
N6022 was administered by intravenous infusion once per day for 7 days
|
20mg/N6022
N6022 was administered by intravenous infusion once per day for 7 days
|
40 mg/N6022
N6022 was administered by intravenous infusion once per day for 7 days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
10
|
9
|
9
|
19
|
|
Overall Study
Enrolled
|
19
|
10
|
9
|
9
|
19
|
|
Overall Study
COMPLETED
|
19
|
10
|
9
|
9
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Baseline characteristics by cohort
| Measure |
Normal Saline
n=19 Participants
Normal saline: IV solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
|
5mg/N6022
n=10 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
10mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
20mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
40mg/N6022
n=19 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 7.27 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 6.33 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 7.84 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
28.4 years
STANDARD_DEVIATION 8.46 • n=21 Participants
|
28.9 years
STANDARD_DEVIATION 7.93 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
66 Participants
n=8 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=8 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=8 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=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=8 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
66 Participants
n=8 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=8 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=8 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
19 participants
n=21 Participants
|
66 participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
21.4 kg/^m2
STANDARD_DEVIATION 3.25 • n=5 Participants
|
21.7 kg/^m2
STANDARD_DEVIATION 4.59 • n=7 Participants
|
21.7 kg/^m2
STANDARD_DEVIATION 2.27 • n=5 Participants
|
21.0 kg/^m2
STANDARD_DEVIATION 3.80 • n=4 Participants
|
22.5 kg/^m2
STANDARD_DEVIATION 2.62 • n=21 Participants
|
21.9 kg/^m2
STANDARD_DEVIATION 3.25 • n=8 Participants
|
|
Weight
|
62.9 kg
STANDARD_DEVIATION 11.50 • n=5 Participants
|
61.8 kg
STANDARD_DEVIATION 11.73 • n=7 Participants
|
59.1 kg
STANDARD_DEVIATION 9.06 • n=5 Participants
|
56.3 kg
STANDARD_DEVIATION 13.59 • n=4 Participants
|
63.8 kg
STANDARD_DEVIATION 12.53 • n=21 Participants
|
61.0 kg
STANDARD_DEVIATION 11.96 • n=8 Participants
|
|
FEV1 (L)
|
2.7 L
STANDARD_DEVIATION 0.85 • n=5 Participants
|
2.6 L
STANDARD_DEVIATION 0.88 • n=7 Participants
|
2.2 L
STANDARD_DEVIATION 0.91 • n=5 Participants
|
2.1 L
STANDARD_DEVIATION 0.66 • n=4 Participants
|
2.8 L
STANDARD_DEVIATION 1.12 • n=21 Participants
|
2.5 L
STANDARD_DEVIATION 0.97 • n=8 Participants
|
|
FEV1 Percent Predicted
|
72.5 percent
STANDARD_DEVIATION 23.7 • n=5 Participants
|
70.7 percent
STANDARD_DEVIATION 19.5 • n=7 Participants
|
63.3 percent
STANDARD_DEVIATION 17.5 • n=5 Participants
|
63.2 percent
STANDARD_DEVIATION 21.1 • n=4 Participants
|
73.9 percent
STANDARD_DEVIATION 21.9 • n=21 Participants
|
70.1 percent
STANDARD_DEVIATION 21.3 • n=8 Participants
|
|
Sweat Chloride
|
100.4 mEq/L
STANDARD_DEVIATION 12.9 • n=5 Participants
|
103.3 mEq/L
STANDARD_DEVIATION 6.9 • n=7 Participants
|
107.3 mEq/L
STANDARD_DEVIATION 6.7 • n=5 Participants
|
93.1 mEq/L
STANDARD_DEVIATION 9.2 • n=4 Participants
|
100.3 mEq/L
STANDARD_DEVIATION 8.3 • n=21 Participants
|
100.8 mEq/L
STANDARD_DEVIATION 10.7 • n=8 Participants
|
PRIMARY outcome
Timeframe: Over 7 treatment days and 7 days of follow-upPopulation: Treatment emergent adverse events by Grade 1 (mild) to 5 (fatal)
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
|
5mg/N6022
n=10 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
10mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
20mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
40mg/N6022
n=19 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
|---|---|---|---|---|---|
|
Safety and Tolerability
Grade 1 (mild)
|
11 participants
|
4 participants
|
6 participants
|
4 participants
|
12 participants
|
|
Safety and Tolerability
Grade 2 (moderate)
|
6 participants
|
3 participants
|
3 participants
|
5 participants
|
2 participants
|
|
Safety and Tolerability
Serious TEAE
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability
Grade 3 (severe)
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety and Tolerability
Grade 4 (life threatening)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability
Grade 5 (fatal)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Change from baseline at Day 7Population: Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Study Day 7
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson standards were used to calculate percent predicted FEV1 (for age, sex, and height).
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
|
5mg/N6022
n=10 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
10mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
20mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
40mg/N6022
n=19 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
|---|---|---|---|---|---|
|
Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
|
1.5 percentage
Standard Deviation 3.44
|
-0.5 percentage
Standard Deviation 4.72
|
-0.2 percentage
Standard Deviation 3.99
|
-0.7 percentage
Standard Deviation 4.08
|
0.5 percentage
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Change from baseline at Day 7Population: Change from baseline sweat chloride (mEq/L) to Study Day 14
Sweat chloride millequivalents/Liter (mEq/L)
Outcome measures
| Measure |
Normal Saline
n=19 Participants
Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
|
5mg/N6022
n=10 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
10mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
20mg/N6022
n=9 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
40mg/N6022
n=19 Participants
N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
|
|---|---|---|---|---|---|
|
Change in Biomarkers of CFTR Function
|
-0.2 mEq/L
Standard Deviation 8.55
|
-2.3 mEq/L
Standard Deviation 8.12
|
-2.9 mEq/L
Standard Deviation 8.84
|
-0.1 mEq/L
Standard Deviation 11.25
|
2.9 mEq/L
Standard Deviation 8.88
|
Adverse Events
Placebo/Saline
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
5 mg/N6022
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
10 mg/N6022
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
20mg/N6022
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
40 mg/N6022
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Saline
n=19 participants at risk
0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
|
5 mg/N6022
n=10 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
10 mg/N6022
n=9 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
20mg/N6022
n=9 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
40 mg/N6022
n=19 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Infections and infestations
Pulmonary Exacerbation of CF
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
Other adverse events
| Measure |
Placebo/Saline
n=19 participants at risk
0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
|
5 mg/N6022
n=10 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
10 mg/N6022
n=9 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
20mg/N6022
n=9 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
40 mg/N6022
n=19 participants at risk
N6022 was administered by intravenous infusion once per day for 7 days
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
22.2%
2/9 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
General disorders
Parosmia
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
22.2%
2/9 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.8%
7/19 • Number of events 7 • Through Study Day 14
Adverse effect must have been present at Day 14
|
30.0%
3/10 • Number of events 3 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
33.3%
3/9 • Number of events 3 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.5%
2/19 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
15.8%
3/19 • Number of events 3 • Through Study Day 14
Adverse effect must have been present at Day 14
|
20.0%
2/10 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
22.2%
2/9 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
22.2%
2/9 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
30.0%
3/10 • Number of events 3 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Chest tightness
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
20.0%
2/10 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.5%
2/19 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
30.0%
3/10 • Number of events 3 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
General disorders
Night Sweats
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
22.2%
2/9 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Ventricular extrasystoles
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.5%
2/19 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
11.1%
1/9 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.5%
2/19 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.5%
2/19 • Number of events 2 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Infections and infestations
Infective Pulmonary Exacerbations of CF
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
10.0%
1/10 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.3%
1/19 • Number of events 1 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/10 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/9 • Through Study Day 14
Adverse effect must have been present at Day 14
|
0.00%
0/19 • Through Study Day 14
Adverse effect must have been present at Day 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60