Trial Outcomes & Findings for Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens (NCT NCT05219669)
NCT ID: NCT05219669
Last Updated: 2024-08-05
Results Overview
Maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
48 hours
Results posted on
2024-08-05
Participant Flow
Participant milestones
| Measure |
Sequence 1
"Sequence 1" represents subjects taking
* Treatment "A" in period 1 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 2 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "C" in period 3 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
|
Sequence 2
"Sequence 2" represents subjects taking
* Treatment "B" in period 1 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "C" in period 2 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "A" in period 3 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
|
Sequence 3
"Sequence 3" represents subjects taking
* Treatment "C" in period 1 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "A" in period 2 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 3 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
|
Sequence 4
"Sequence 4" represents subjects taking
* Treatment "A" in period 1 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "C" in period 2 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 3 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
|
Sequence 5
"Sequence 5" represents subjects taking
* Treatment "B" in period 1 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "A" in period 2 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "C" in period 3 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
|
Sequence 6
"Sequence 6" represents subjects taking
* Treatment "C" in period 1 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 2 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "A" in period 3 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
|
|---|---|---|---|---|---|---|
|
Period 1 (1 Day)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period 1 (1 Day)
COMPLETED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout (6 Days)
STARTED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Washout (6 Days)
COMPLETED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Washout (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (1 Day)
STARTED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Period 2 (1 Day)
COMPLETED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (1 Day)
STARTED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Period 3 (1 Day)
COMPLETED
|
4
|
4
|
3
|
4
|
4
|
4
|
|
Period 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
"Sequence 1" represents subjects taking
* Treatment "A" in period 1 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 2 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "C" in period 3 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
|
Sequence 2
"Sequence 2" represents subjects taking
* Treatment "B" in period 1 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "C" in period 2 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "A" in period 3 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
|
Sequence 3
"Sequence 3" represents subjects taking
* Treatment "C" in period 1 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "A" in period 2 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 3 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
|
Sequence 4
"Sequence 4" represents subjects taking
* Treatment "A" in period 1 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "C" in period 2 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 3 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
|
Sequence 5
"Sequence 5" represents subjects taking
* Treatment "B" in period 1 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "A" in period 2 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "C" in period 3 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
|
Sequence 6
"Sequence 6" represents subjects taking
* Treatment "C" in period 1 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 2 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "A" in period 3 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
|
|---|---|---|---|---|---|---|
|
Period 1 (1 Day)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
Baseline characteristics by cohort
| Measure |
Sequence 1
n=4 Participants
"Sequence 1" represents subjects taking
* Treatment "A" in period 1 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 2 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "C" in period 3 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
|
Sequence 2
n=4 Participants
"Sequence 2" represents subjects taking
* Treatment "B" in period 1 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "C" in period 2 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "A" in period 3 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
|
Sequence 3
n=4 Participants
"Sequence 3" represents subjects taking
* Treatment "C" in period 1 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "A" in period 2 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 3 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
|
Sequence 4
n=4 Participants
"Sequence 4" represents subjects taking
* Treatment "A" in period 1 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "C" in period 2 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 3 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
|
Sequence 5
n=4 Participants
"Sequence 5" represents subjects taking
* Treatment "B" in period 1 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "A" in period 2 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
* Treatment "C" in period 3 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
|
Sequence 6
n=4 Participants
"Sequence 6" represents subjects taking
* Treatment "C" in period 1 (6 mg IN nalmefene dose \[two 0.1 mL sprays of a 30 mg/mL solution in one nostril\])
* Treatment "B" in period 2 (6 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in each nostril\])
* Treatment "A" in period 3 (3 mg IN nalmefene dose \[one 0.1 mL spray of a 30 mg/mL solution in one nostril\])
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 5.91 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 12.40 • n=4 Participants
|
28.0 years
STANDARD_DEVIATION 6.73 • n=21 Participants
|
27.0 years
STANDARD_DEVIATION 6.06 • n=8 Participants
|
31.2 years
STANDARD_DEVIATION 8.47 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 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
|
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
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=8 Participants
|
24 participants
n=8 Participants
|
|
BMI
|
26.28 kg/m2
STANDARD_DEVIATION 4.853 • n=5 Participants
|
25.80 kg/m2
STANDARD_DEVIATION 2.226 • n=7 Participants
|
24.30 kg/m2
STANDARD_DEVIATION 2.426 • n=5 Participants
|
23.18 kg/m2
STANDARD_DEVIATION 4.921 • n=4 Participants
|
23.00 kg/m2
STANDARD_DEVIATION 2.362 • n=21 Participants
|
24.58 kg/m2
STANDARD_DEVIATION 3.222 • n=8 Participants
|
24.52 kg/m2
STANDARD_DEVIATION 3.357 • n=8 Participants
|
PRIMARY outcome
Timeframe: 48 hoursMaximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
Outcome measures
| Measure |
Intranasal Nalmefene 1 Spray in 1 Nostril
n=23 Participants
3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 2 Sprays in 1 Nostril
n=24 Participants
6 mg IN Nalmefene Hydrochloride dose (two 0.1 mL sprays of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 1 Spray in Each Nostril
n=23 Participants
6 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in each nostril)
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
10.8 ng/ml
Standard Deviation 4.87
|
18.9 ng/ml
Standard Deviation 11.2
|
22.2 ng/ml
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: 48 hoursTime to maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
Outcome measures
| Measure |
Intranasal Nalmefene 1 Spray in 1 Nostril
n=23 Participants
3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 2 Sprays in 1 Nostril
n=24 Participants
6 mg IN Nalmefene Hydrochloride dose (two 0.1 mL sprays of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 1 Spray in Each Nostril
n=23 Participants
6 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in each nostril)
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
0.267 hours
Interval 0.167 to 2.03
|
0.25 hours
Interval 0.117 to 3.0
|
0.25 hours
Interval 0.117 to 2.03
|
PRIMARY outcome
Timeframe: 48 hoursArea under the curve of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
Outcome measures
| Measure |
Intranasal Nalmefene 1 Spray in 1 Nostril
n=23 Participants
3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 2 Sprays in 1 Nostril
n=24 Participants
6 mg IN Nalmefene Hydrochloride dose (two 0.1 mL sprays of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 1 Spray in Each Nostril
n=23 Participants
6 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in each nostril)
|
|---|---|---|---|
|
Area Under the Curve (AUC)
|
46.8 AUCinf (ng·h/mL)
Standard Deviation 10.1
|
85.7 AUCinf (ng·h/mL)
Standard Deviation 18.7
|
89.5 AUCinf (ng·h/mL)
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: 48 hoursHalf life of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril
Outcome measures
| Measure |
Intranasal Nalmefene 1 Spray in 1 Nostril
n=23 Participants
3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 2 Sprays in 1 Nostril
n=24 Participants
6 mg IN Nalmefene Hydrochloride dose (two 0.1 mL sprays of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 1 Spray in Each Nostril
n=23 Participants
6 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in each nostril)
|
|---|---|---|---|
|
Half-life (t1/2)
|
11.4 hour
Standard Deviation 2.51
|
11.3 hour
Standard Deviation 1.86
|
11.3 hour
Standard Deviation 1.87
|
Adverse Events
Intranasal Nalmefene 1 Spray in 1 Nostril
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Intranasal Nalmefene 2 Sprays in 1 Nostril
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Intranasal Nalmefene 1 Spray in Each Nostril
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Nalmefene 1 Spray in 1 Nostril
n=23 participants at risk
3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 2 Sprays in 1 Nostril
n=24 participants at risk
6 mg IN Nalmefene Hydrochloride dose (two 0.1 mL sprays of a 30 mg/mL solution in one nostril)
|
Intranasal Nalmefene 1 Spray in Each Nostril
n=23 participants at risk
6 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in each nostril)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
13.0%
3/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
25.0%
6/24 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
8.7%
2/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.3%
1/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
16.7%
4/24 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
4.3%
1/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
4.3%
1/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
12.5%
3/24 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
13.0%
3/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
4.2%
1/24 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
21.7%
5/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
0.00%
0/24 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
4.3%
1/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
8.3%
2/24 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
0.00%
0/23 • Subjects were collected AE from baseline to day 15 with a +3 to 5 day follow-up. During the 15 days in clinic they received one of the three doing regimens on day 1, 7 and 13.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place