Trial Outcomes & Findings for Pharmacokinetic Evaluation of Intranasal Nalmefene (NCT NCT04759768)
NCT ID: NCT04759768
Last Updated: 2024-08-13
Results Overview
Maximum concentration of plasma nalmefene comparing IN to IM
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
48 hours
Results posted on
2024-08-13
Participant Flow
Complete
Participant milestones
| Measure |
Intranasal Nalmefene Then Intramuscular Nalmefene
3 mg nalmefene hydrochloride intranasally (1 spray) then 1 mg nalmefene hydrochloride solution intramuscularly (single dose)
|
Intramuscular Nalmefene Then Intranasal Nalmefene
1 mg nalmefene hydrochloride solution intramuscularly (single dose) then 3 mg nalmefene hydrochloride intranasally (1 spray)
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
34
|
34
|
|
First Intervention (1 Day)
COMPLETED
|
34
|
34
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
34
|
34
|
|
Washout (7 Days)
COMPLETED
|
34
|
32
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
2
|
|
Second Intervention (1 Day)
STARTED
|
34
|
32
|
|
Second Intervention (1 Day)
COMPLETED
|
34
|
32
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Intranasal Nalmefene Then Intramuscular Nalmefene
3 mg nalmefene hydrochloride intranasally (1 spray) then 1 mg nalmefene hydrochloride solution intramuscularly (single dose)
|
Intramuscular Nalmefene Then Intranasal Nalmefene
1 mg nalmefene hydrochloride solution intramuscularly (single dose) then 3 mg nalmefene hydrochloride intranasally (1 spray)
|
|---|---|---|
|
Washout (7 Days)
Withdrawal by Subject
|
0
|
1
|
|
Washout (7 Days)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Pharmacokinetic Evaluation of Intranasal Nalmefene
Baseline characteristics by cohort
| Measure |
Intranasal Nalmefene Then Intramuscular Nalmefene
n=34 Participants
3 mg nalmefene hydrochloride intranasally (1 spray) then 1 mg nalmefene hydrochloride solution intramuscularly (single dose)
|
Intramuscular Nalmefene Then Intranasal Nalmefene
n=34 Participants
1 mg nalmefene hydrochloride solution intramuscularly (single dose) then 3 mg nalmefene hydrochloride intranasally (1 spray)
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 18 to 55 years old
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other specific islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
BMI
|
26.58 kg/m2
STANDARD_DEVIATION 2.540 • n=5 Participants
|
25.60 kg/m2
STANDARD_DEVIATION 2.996 • n=7 Participants
|
26.09 kg/m2
STANDARD_DEVIATION 2.800 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursMaximum concentration of plasma nalmefene comparing IN to IM
Outcome measures
| Measure |
Intranasal Nalmefene
n=66 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene Hydrochloride: 3mg nasal spray
|
Intramuscular Nalmefene
n=68 Participants
Nalmefene injection, 1mg, 1 injection
Nalmefene: 1mg intramuscular injection
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
12.2 ng/ml
Standard Deviation 6.71
|
1.77 ng/ml
Standard Deviation 1.18
|
PRIMARY outcome
Timeframe: 48 hoursTime to maximum concentration of plasma nalmefene comparing IN to IM
Outcome measures
| Measure |
Intranasal Nalmefene
n=66 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene Hydrochloride: 3mg nasal spray
|
Intramuscular Nalmefene
n=68 Participants
Nalmefene injection, 1mg, 1 injection
Nalmefene: 1mg intramuscular injection
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
0.25 hours
Interval 0.0833 to 2.0
|
0.333 hours
Interval 0.117 to 18.0
|
PRIMARY outcome
Timeframe: 48 hoursArea under the curve of plasma nalmefene comparing IN to IM
Outcome measures
| Measure |
Intranasal Nalmefene
n=66 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene Hydrochloride: 3mg nasal spray
|
Intramuscular Nalmefene
n=68 Participants
Nalmefene injection, 1mg, 1 injection
Nalmefene: 1mg intramuscular injection
|
|---|---|---|
|
Area Under the Curve (AUC-inf)
|
41.5 hour*ng/mL
Standard Deviation 8.45
|
17.0 hour*ng/mL
Standard Deviation 3.13
|
PRIMARY outcome
Timeframe: 48 hoursHalf life of plasma nalmefene comparing IN to IM
Outcome measures
| Measure |
Intranasal Nalmefene
n=66 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene Hydrochloride: 3mg nasal spray
|
Intramuscular Nalmefene
n=68 Participants
Nalmefene injection, 1mg, 1 injection
Nalmefene: 1mg intramuscular injection
|
|---|---|---|
|
Half-life (t1/2)
|
11.4 hour
Standard Deviation 2.37
|
10.6 hour
Standard Deviation 1.95
|
Adverse Events
Intranasal Nalmefene
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Intramuscular Nalmefene
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Nalmefene
n=66 participants at risk
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene Hydrochloride: 3mg nasal spray
|
Intramuscular Nalmefene
n=68 participants at risk
Nalmefene injection, 1mg, 1 injection
Nalmefene: 1mg intramuscular injection
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
56.1%
37/66 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
0.00%
0/68 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
|
Nervous system disorders
headache
|
4.5%
3/66 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
5.9%
4/68 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
|
Gastrointestinal disorders
nausea
|
3.0%
2/66 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
5.9%
4/68 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
|
Nervous system disorders
dizziness
|
6.1%
4/66 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
1.5%
1/68 • Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place