Drug OverdosePhase 1NCT02572089
Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
A Phase 1 study testing Naloxone in people with Drug Overdose and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Overdose, Opioid-Related Disorders
- What is being tested?
- Naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able to provide written consent
- Must have a BMI ranging from 18 to 30kg/m2, inclusive
- Must have adequate venous access
- Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.
- Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
- Must agree to not ingest alcohol, drinks containing xanthine greater than 500 mg/day (e.g., Coca Cola, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
Who cannot join
- Please contact clinical site directly for more information
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
- Conditions
- Drug Overdose, Opioid-Related Disorders
- Being tested
- Naloxone
- Medical subject headings
- Drug Overdose, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaloxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| 2mg Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 20 mg/mL formulation in one nostril Receives: Drug: Naloxone |
| 4mg(a) Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 20 mg/mL formulation in both nostrils Receives: Drug: Naloxone |
| 4mg(b) Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 40mg/mL formulation in one nostril Receives: Drug: Naloxone |
| 8mg Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 40mg/mL formulation in both nostrils Receives: Drug: Naloxone |
| Intramuscular Naloxone | Experimental | Administer 1mL of 0.4mg/mL formulation intramuscularly Receives: Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration.
Measured: 720 minutes
Time at Maximum Plasma Concentration (Tmax)
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Measured: 720 minutes
Area Under the Concentration (AUC 0-t)
Time curve from time zero to last measurable concentration. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Measured: 720 minutes
Area Under Curve (AUC 0-inf)
Time curve from time zero to infinity. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Measured: 720 minutes
Half-life
The apparent terminal exponential half-life. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Measured: 720 minutes
Secondary outcomes (4)
Adverse events
will be reported from the start of the first session to the follow-up visit
Measured: minimum of 18 days
Vital Signs
Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration.
Measured: 480 minutes
12-lead electrocardiogram
Measured at pre-dose and at times 60 and 480 minutes after naloxone administration.
Measured: 480 minutes
Nasal Irritation Scoring
Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Vince & Associates Clinical Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572089
- Sponsor's protocol ID
- Naloxone-Phase1a-002
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02572089
- Acronym / sponsor ID
- Naloxone-Phase1a-002
- Conditions
- Drug Overdose, Opioid-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Vince & Associates Clinical Research, Inc.
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2mg Intranasal Naloxone | Experimental | Drug: NaloxoneAdminister 0.1mL spray of the 20 mg/mL formulation in one nostril |
| 4mg(a) Intranasal Naloxone | Experimental | Drug: NaloxoneAdminister 0.1mL spray of the 20 mg/mL formulation in both nostrils |
| 4mg(b) Intranasal Naloxone | Experimental | Drug: NaloxoneAdminister 0.1mL spray of the 40mg/mL formulation in one nostril |
| 8mg Intranasal Naloxone | Experimental | Drug: NaloxoneAdminister 0.1mL spray of the 40mg/mL formulation in both nostrils |
| Intramuscular Naloxone | Experimental | Drug: NaloxoneAdminister 1mL of 0.4mg/mL formulation intramuscularly |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be able to provide written consent
- Must have a BMI ranging from 18 to 30kg/m2, inclusive
- Must have adequate venous access
- Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.
- Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
Key exclusion criteria (1 listed)
- Please contact clinical site directly for more information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naloxone | Drug | 2mg Intranasal Naloxone, 4mg(a) Intranasal Naloxone, 4mg(b) Intranasal Naloxone, 8mg Intranasal Naloxone, Intramuscular Naloxone |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 720 minutes
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration.
Time at Maximum Plasma Concentration (Tmax)
Time frame: 720 minutes
Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Area Under the Concentration (AUC 0-t)
Time frame: 720 minutes
Time curve from time zero to last measurable concentration. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Area Under Curve (AUC 0-inf)
Time frame: 720 minutes
Time curve from time zero to infinity. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
Half-life
Time frame: 720 minutes
The apparent terminal exponential half-life. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration
4 secondary outcomes
Adverse events
Time frame: minimum of 18 days
Vital Signs
Time frame: 480 minutes
12-lead electrocardiogram
Time frame: 480 minutes
Nasal Irritation Scoring
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naloxone in people with Drug Overdose and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: 720 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.