Trial Outcomes & Findings for Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. (NCT NCT06306391)
NCT ID: NCT06306391
Last Updated: 2026-05-06
Results Overview
To assess the effects of naloxone on HR; only results at 6 hours will be reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Up to 6 hours.
Results posted on
2026-05-06
Participant Flow
From March 2024 to May 2024, participants were recruited from the Clinical Research Unit database of the Mar Hospital Research Institute.
Participant milestones
| Measure |
Group A: Intranasal - Washout Period - Intravenous
During Period 1, participants received a single dose of intranasal naloxone (Nyxoid® 1.8 mg nasal spray; Mundipharma Pharmaceuticals, S.L.). Following a washout period of at least 3 days, participants received a single intravenous dose of naloxone (1 mg; Naloxona Kern Pharma 0.4 mg/mL solution for injection) in Period 2.
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Group B: Intravenous - Washout Period - Intranasal
During Period 1, participants received a single intravenous dose of naloxone (1 mg; Naloxona Kern Pharma 0.4 mg/mL solution for injection). Following a washout period of at least 3 days, participants received a single dose of intranasal naloxone (Nyxoid® 1.8 mg nasal spray; Mundipharma Pharmaceuticals, S.L.) in Period 2.
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|---|---|---|
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Overall Study
STARTED
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4
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4
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Overall Study
COMPLETED
|
4
|
4
|
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Overall Study
NOT COMPLETED
|
0
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=8 Participants
Healthy adult participants enrolled in this randomized crossover study evaluating intranasal and intravenous of naloxone.
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|---|---|
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Age, Customized
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31.3 years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
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Sex: Female, Male
Female
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2 Participants
n=8 Participants
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Sex: Female, Male
Male
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6 Participants
n=8 Participants
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Body Mass Index (BMI)
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25.3 kg/m^2
STANDARD_DEVIATION 1.9 • n=8 Participants
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PRIMARY outcome
Timeframe: Up to 6 hours.To assess the effects of naloxone on HR; only results at 6 hours will be reported.
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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Effects of Naloxone on Heart Rate (HR).
|
73.3 bpm
Standard Deviation 9.5
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70.6 bpm
Standard Deviation 10.8
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PRIMARY outcome
Timeframe: Up to 6 hours.To assess the effects of naloxone on SBP; only results at 6 hours will be reported.
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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Effects of Naloxone on Systolic Blood Pressure (SBP).
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120.8 mmHg
Standard Deviation 9.5
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121.0 mmHg
Standard Deviation 11.4
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PRIMARY outcome
Timeframe: Up to 6 hoursTo assess the effects of naloxone on DBP; only results at 6 hours will be reported.
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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Effects of Naloxone on Diastolic Blood Pressure (DBP).
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69.7 mmHg
Standard Deviation 8.3
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69.5 mmHg
Standard Deviation 7.7
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PRIMARY outcome
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each DoseThe mean maximum observed concentration (of intranasal and intravenous naloxone), calculated from individual plasma PK concentrations
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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Cmax
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5.1 ng/mL
Standard Deviation 2.8
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27.4 ng/mL
Standard Deviation 10.9
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PRIMARY outcome
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each DoseTime of maximum observed concentration (of intranasal and intravenous naloxone), calculated from individual plasma PK concentrations.
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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Tmax
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22.5 min
Interval 15.0 to 45.0
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2.0 min
Interval 2.0 to 2.0
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PRIMARY outcome
Timeframe: up to 24 hoursArea under the curve from 0 time to the last measurable concentration (of intravenous and intranasal naloxone), calculated from individual plasma PK concentrations.
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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AUC(0-24h)
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448.9 ng·min/mL
Standard Deviation 98.6
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279.1 ng·min/mL
Standard Deviation 37.7
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SECONDARY outcome
Timeframe: Up to 24 hours.AE was performed including number and percentage.
Outcome measures
| Measure |
Group:Intranasal
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 Participants
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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Adverse Effects (AE)
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2 Participants
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0 Participants
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Adverse Events
Group: Intranasal
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group: Intravenous
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group: Intranasal
n=8 participants at risk
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
|
Group: Intravenous
n=8 participants at risk
Participants were randomized to one of two treatment sequences:
* Sequence A: Intranasal - Wash out - Intravenous.
* Sequence B: Intravenous - Wash out - Intravenous. Results are presented by treatment received
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|---|---|---|
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General disorders
Fever
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12.5%
1/8 • From day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
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0.00%
0/8 • From day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
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Gastrointestinal disorders
Odynophagia
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12.5%
1/8 • From day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
0.00%
0/8 • From day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
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Gastrointestinal disorders
Diarrhea
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12.5%
1/8 • From day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
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0.00%
0/8 • From day 1 to End of Study, up to 24 hours
The participants were healthy volunteers, and the effects of the medication are well known.
|
Additional Information
Rafael de la Torre Fornell/Ana M aldea Perona
Consorci PSMAR
Phone: (+34) 93 3160484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place