Trial Outcomes & Findings for Pharmacodynamic Evaluation of Intranasal Nalmefene (NCT NCT04828005)
NCT ID: NCT04828005
Last Updated: 2025-07-14
Results Overview
Change in minute ventilation from opioid induced nadir
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
5 minutes
Results posted on
2025-07-14
Participant Flow
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; outcome measures were not collected in Part 1. Part 2 participant flow was only reported as one group (i.e., it is not possible to show how many participants received each intervention).
Participant milestones
| Measure |
Part 1 Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 1
* Healthy volunteers with prior opioid exposure received pretreatment with ondansetron (8 mg, oral) and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 5 minutes.
* Subjects received 4 mg IN naloxone hydrochloride at Time 25 minutes.
* Remifentanil infusion continued up to Time 115 minutes.
|
Part 1 Extension Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone
Subjects received First Treatment (1 Day) only. Treatment in Part 1 Extension.
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* Subjects then received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* IN naloxone hydrochloride was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
Part 2: Intranasal Nalmefene Crossover to Intranasal Naloxone
Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 2
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.
* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
Part 2: Intranasal Naloxone Crossover to Intranasal Nalmefene
Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 2
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.
* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
|---|---|---|---|---|
|
Part 1 Setup: 1st Treatment (1 Day)
STARTED
|
7
|
0
|
0
|
0
|
|
Part 1 Setup: 1st Treatment (1 Day)
COMPLETED
|
7
|
0
|
0
|
0
|
|
Part 1 Setup: 1st Treatment (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1 Setup: Washout (4 Days)
STARTED
|
7
|
0
|
0
|
0
|
|
Part 1 Setup: Washout (4 Days)
COMPLETED
|
5
|
0
|
0
|
0
|
|
Part 1 Setup: Washout (4 Days)
NOT COMPLETED
|
2
|
0
|
0
|
0
|
|
Part 1 Setup: 2nd Treatment (1 Day)
STARTED
|
5
|
0
|
0
|
0
|
|
Part 1 Setup: 2nd Treatment (1 Day)
COMPLETED
|
5
|
0
|
0
|
0
|
|
Part 1 Setup: 2nd Treatment (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1 Extension: 1st Treatment (1 Day)
STARTED
|
0
|
8
|
0
|
0
|
|
Part 1 Extension: 1st Treatment (1 Day)
COMPLETED
|
0
|
8
|
0
|
0
|
|
Part 1 Extension: 1st Treatment (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2: 1st Treatment (1 Day)
STARTED
|
0
|
0
|
34
|
35
|
|
Part 2: 1st Treatment (1 Day)
COMPLETED
|
0
|
0
|
27
|
32
|
|
Part 2: 1st Treatment (1 Day)
NOT COMPLETED
|
0
|
0
|
7
|
3
|
|
Part 2: Washout (4 Days)
STARTED
|
0
|
0
|
27
|
32
|
|
Part 2: Washout (4 Days)
COMPLETED
|
0
|
0
|
25
|
30
|
|
Part 2: Washout (4 Days)
NOT COMPLETED
|
0
|
0
|
2
|
2
|
|
Part 2: 2nd Treatment (1 Day)
STARTED
|
0
|
0
|
25
|
30
|
|
Part 2: 2nd Treatment (1 Day)
COMPLETED
|
0
|
0
|
25
|
27
|
|
Part 2: 2nd Treatment (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Part 1 Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 1
* Healthy volunteers with prior opioid exposure received pretreatment with ondansetron (8 mg, oral) and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 5 minutes.
* Subjects received 4 mg IN naloxone hydrochloride at Time 25 minutes.
* Remifentanil infusion continued up to Time 115 minutes.
|
Part 1 Extension Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone
Subjects received First Treatment (1 Day) only. Treatment in Part 1 Extension.
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* Subjects then received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* IN naloxone hydrochloride was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
Part 2: Intranasal Nalmefene Crossover to Intranasal Naloxone
Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 2
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.
* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
Part 2: Intranasal Naloxone Crossover to Intranasal Nalmefene
Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 2
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.
* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
|---|---|---|---|---|
|
Part 1 Setup: Washout (4 Days)
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Part 2: 1st Treatment (1 Day)
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
|
Part 2: 1st Treatment (1 Day)
Adverse Event
|
0
|
0
|
3
|
0
|
|
Part 2: 1st Treatment (1 Day)
Protocol Violation
|
0
|
0
|
2
|
1
|
|
Part 2: 1st Treatment (1 Day)
Equipment failure
|
0
|
0
|
0
|
1
|
|
Part 2: Washout (4 Days)
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
|
Part 2: Washout (4 Days)
Physician Decision
|
0
|
0
|
0
|
2
|
|
Part 2: 2nd Treatment (1 Day)
Protocol Violation
|
0
|
0
|
0
|
2
|
|
Part 2: 2nd Treatment (1 Day)
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pharmacodynamic Evaluation of Intranasal Nalmefene
Baseline characteristics by cohort
| Measure |
Part 1: Intranasal Nalmefene
n=7 Participants
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 1
* Healthy volunteers with prior opioid exposure received pretreatment with ondansetron (8 mg, oral) and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 5 minutes.
* Subjects received 4 mg IN naloxone hydrochloride at Time 25 minutes.
* Remifentanil infusion continued up to Time 115 minutes.
|
Part 1 Extension: Intranasal Nalmefene
n=8 Participants
Subjects received First Treatment (1 Day) only. Treatment in Part 1 Extension.
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* Subjects then received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* IN naloxone hydrochloride was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
Part 2: Intranasal Nalmefene Compared to Intranasal Naloxone
n=69 Participants
Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.
Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).
Treatment in Part 2
* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.
* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.
* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.
* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.
* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.
* Remifentanil infusion continued up to Time 146 minutes.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
28.6 years
STANDARD_DEVIATION 4.50 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 11.05 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 7.79 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 7.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
69 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
BMI
|
25.03 kg/m2
STANDARD_DEVIATION 3.338 • n=5 Participants
|
24.48 kg/m2
STANDARD_DEVIATION 3.665 • n=7 Participants
|
25.27 kg/m2
STANDARD_DEVIATION 3.316 • n=5 Participants
|
25.17 kg/m2
STANDARD_DEVIATION 3.317 • n=4 Participants
|
|
Weight
|
79.13 kg
STANDARD_DEVIATION 16.616 • n=5 Participants
|
78.65 kg
STANDARD_DEVIATION 9.735 • n=7 Participants
|
78.30 kg
STANDARD_DEVIATION 14.120 • n=5 Participants
|
78.40 kg
STANDARD_DEVIATION 13.833 • n=4 Participants
|
|
Height
|
178.7 cm
STANDARD_DEVIATION 9.71 • n=5 Participants
|
179.8 cm
STANDARD_DEVIATION 9.38 • n=7 Participants
|
175.6 cm
STANDARD_DEVIATION 10.21 • n=5 Participants
|
176.3 cm
STANDARD_DEVIATION 10.08 • n=4 Participants
|
PRIMARY outcome
Timeframe: 5 minutesChange in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=60 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=59 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Change in Minute Ventilation
|
5.744 L/min
Standard Error 0.6240
|
3.432 L/min
Standard Error 0.6117
|
SECONDARY outcome
Timeframe: Up to 2 hoursMaximum change in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=60 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=61 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Maximum Change in Minute Ventilation
|
5.8 ng/mL
Standard Deviation 3.0
|
6.8 ng/mL
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Up to 2 hoursTime to maximum change in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=60 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=61 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Time to Maximum Change in Minute Ventilation
|
0.75 hour
Interval 0.13 to 2.0
|
0.50 hour
Interval 0.04 to 2.0
|
SECONDARY outcome
Timeframe: 90 minutesChange in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=56 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=59 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Change in Minute Ventilation
|
2.14 L/min
Standard Error 0.62
|
2.71 L/min
Standard Error 0.59
|
SECONDARY outcome
Timeframe: 20 minutesChange in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=59 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=60 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Change in Minute Ventilation
|
5.93 L/min
Standard Error 0.68
|
6.79 L/min
Standard Error 0.71
|
SECONDARY outcome
Timeframe: 15 minutesChange in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=59 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=61 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Change in Minute Ventilation
|
5.55 L/min
Standard Error 0.64
|
7.12 L/min
Standard Error 0.77
|
SECONDARY outcome
Timeframe: 10 minutesChange in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=59 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=61 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Change in Minute Ventilation
|
4.96 L/min
Standard Error 0.69
|
6.58 L/min
Standard Error 0.66
|
SECONDARY outcome
Timeframe: 2.5 minutesChange in minute ventilation from opioid induced nadir
Outcome measures
| Measure |
Intranasal Naloxone
n=59 Participants
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
Intranasal Nalmefene
n=60 Participants
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
|---|---|---|
|
Change in Minute Ventilation
|
1.71 L/min
Standard Error 0.53
|
2.55 L/min
Standard Error 0.38
|
Adverse Events
Intranasal Nalmefene
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Intranasal Naloxone
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Nalmefene
n=61 participants at risk
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Nalmefene hydrochloride: 3mg Nasal spray
|
Intranasal Naloxone
n=60 participants at risk
Naloxone hydrochloride nasal spray, 4mg, 1 spray
Naloxone hydrochloride: 4mg Nasal Spray
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
39.3%
24/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
41.7%
25/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
7/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
23.3%
14/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.6%
4/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
0.00%
0/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
General disorders
Fatigue
|
9.8%
6/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
3.3%
2/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Nervous system disorders
Headache
|
59.0%
36/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
58.3%
35/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Nervous system disorders
Dizziness
|
18.0%
11/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
21.7%
13/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Nervous system disorders
Dysgeusia
|
3.3%
2/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
8.3%
5/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Nervous system disorders
Somnolence
|
3.3%
2/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
6.7%
4/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Psychiatric disorders
Anxiety
|
16.4%
10/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
6.7%
4/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
3.3%
2/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
6.7%
4/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
8.2%
5/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
0.00%
0/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidosis
|
6.6%
4/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
1.7%
1/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
|
Vascular disorders
Hot Flush
|
23.0%
14/61 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
11.7%
7/60 • Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5
Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place