Healthy VolunteerPhase 1NCT03827629

A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers

A Phase 1 study testing Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray and Treatment C: Naloxone HCL Intramuscular (IM) Injection in people with Healthy Volunteer, run by INSYS Therapeutics Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray and Treatment C: Naloxone HCL Intramuscular (IM) Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2017to 16 Aug 2017
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A minimum body weight of 50 kg and a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2)
A seated blood pressure between 90 and 140 millimeters of mercury (mmHg) systolic/50 and 90 mmHg diastolic (inclusive)
Female subjects had a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening

Who cannot join

A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients.
Any documented clinically significant infection, injury, or illness within 1 month prior to screening.
An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening.
A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening. Alcohol abuse was defined as greater than 14 drinks per week.
Positive serology test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
A positive urine test result for alcohol, drugs, or cotinine at screening or check-in.

Show all 10Show fewer

A condition that the Investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk.
Used any opioids for 30 days prior to Day 1.
Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestion.

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, Crossover, Comparative Bioavailability Study of Naloxone Nasal Spray and Naloxone Hydrochloride Intramuscular Injection in Healthy Volunteers

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.

Conditions: Healthy Volunteer
Being tested: Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCL Intramuscular (IM) Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A: Naloxone Nasal SprayDrug
Participants received naloxone nasal spray following a 10 hour fast.
Treatment B: Naloxone Nasal SprayDrug
Participants received naloxone nasal spray following a 10 hour fast.
Treatment C: Naloxone HCL Intramuscular (IM) InjectionDrug
Participants received naloxone HCl IM injection following a 10 hour fast.

Study groups in NCT03827629
Study group	Role	What they receive
Cohort 1: Treatment Sequence A-B-C	Experimental	Participants received Treatment A on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment C on Day 1 of Period 3. Receives: Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray; Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Cohort 2: Treatment Sequence B-C-A	Experimental	Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment A on Day 1 of Period 3. Receives: Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray; Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Cohort 3: Treatment Sequence C-A-B	Experimental	Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment B on Day 1 of Period 3. Receives: Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray; Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Cohort 4: Treatment Sequence A-C-B	Experimental	Participants received Treatment A on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment B on Day 1 of Period 3. Receives: Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray; Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Cohort 5: Treatment Sequence C-B-A	Experimental	Participants received Treatment C on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment A on Day 1 of Period 3. Receives: Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray; Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Cohort 6: Treatment Sequence B-A-C	Experimental	Participants received Treatment B on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment C on Day 1 of Period 3. Receives: Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray; Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Concentration of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 1 hour post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 1 hour post-dose

Secondary outcomes (11)

Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Last Quantifiable Concentration (Clast) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Time of the Last Quantifiable Concentration (Tlast) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone
Measured: Pre-dose and at multiple time points up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A serious AE (SAE) is any AE that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention.
Measured: Day 1 up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 201716 Aug 2017

First posted1 Feb 2019
Study start7 Aug 2017
Primary completion16 Aug 2017
Study completion16 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03827629
Sponsor's protocol ID: INS012-17-108
Status last verified: Jan 2019
First submitted: 31 Jan 2019
Last updated: 1 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, Crossover, Comparative Bioavailability Study of Naloxone Nasal Spray and Naloxone Hydrochloride Intramuscular Injection in Healthy Volunteers
ClinicalTrials.gov ID: NCT03827629
Acronym / sponsor ID: INS012-17-108
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: INSYS Therapeutics IncIndustry (pharma, biotech, devices)
Study start: 7 Aug 2017 (actual)
Primary completion: 16 Aug 2017 (actual)
Study completion: 16 Aug 2017 (actual)
First posted: 1 Feb 2019 (actual)
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.

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Cohort 1: Treatment Sequence A-B-C	Experimental	Drug: Treatment A: Naloxone Nasal Spray, Drug: Treatment B: Naloxone Nasal Spray, Drug: Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received Treatment A on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment C on Day 1 of Period 3.
Cohort 2: Treatment Sequence B-C-A	Experimental	Drug: Treatment A: Naloxone Nasal Spray, Drug: Treatment B: Naloxone Nasal Spray, Drug: Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment A on Day 1 of Period 3.
Cohort 3: Treatment Sequence C-A-B	Experimental	Drug: Treatment A: Naloxone Nasal Spray, Drug: Treatment B: Naloxone Nasal Spray, Drug: Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment B on Day 1 of Period 3.
Cohort 4: Treatment Sequence A-C-B	Experimental	Drug: Treatment A: Naloxone Nasal Spray, Drug: Treatment B: Naloxone Nasal Spray, Drug: Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received Treatment A on Day 1 of Period 1, Treatment C on Day 1 of Period 2, and Treatment B on Day 1 of Period 3.
Cohort 5: Treatment Sequence C-B-A	Experimental	Drug: Treatment A: Naloxone Nasal Spray, Drug: Treatment B: Naloxone Nasal Spray, Drug: Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received Treatment C on Day 1 of Period 1, Treatment B on Day 1 of Period 2, and Treatment A on Day 1 of Period 3.
Cohort 6: Treatment Sequence B-A-C	Experimental	Drug: Treatment A: Naloxone Nasal Spray, Drug: Treatment B: Naloxone Nasal Spray, Drug: Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received Treatment B on Day 1 of Period 1, Treatment A on Day 1 of Period 2, and Treatment C on Day 1 of Period 3.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

A minimum body weight of 50 kg and a body mass index (BMI) between 18.0 and 32.0 kilogram per square meter (kg/m2)
A seated blood pressure between 90 and 140 millimeters of mercury (mmHg) systolic/50 and 90 mmHg diastolic (inclusive)
Female subjects had a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening

Key exclusion criteria (10 listed)

A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients.
Any documented clinically significant infection, injury, or illness within 1 month prior to screening.
An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening.
A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening. Alcohol abuse was defined as greater than 14 drinks per week.
Positive serology test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.

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
Treatment A: Naloxone Nasal SprayParticipants received naloxone nasal spray following a 10 hour fast.	Drug	Cohort 1: Treatment Sequence A-B-C, Cohort 2: Treatment Sequence B-C-A, Cohort 3: Treatment Sequence C-A-B, Cohort 4: Treatment Sequence A-C-B, Cohort 5: Treatment Sequence C-B-A, Cohort 6: Treatment Sequence B-A-C
Treatment B: Naloxone Nasal SprayParticipants received naloxone nasal spray following a 10 hour fast.	Drug	Cohort 1: Treatment Sequence A-B-C, Cohort 2: Treatment Sequence B-C-A, Cohort 3: Treatment Sequence C-A-B, Cohort 4: Treatment Sequence A-C-B, Cohort 5: Treatment Sequence C-B-A, Cohort 6: Treatment Sequence B-A-C
Treatment C: Naloxone HCL Intramuscular (IM) InjectionParticipants received naloxone HCl IM injection following a 10 hour fast.	Drug	Cohort 1: Treatment Sequence A-B-C, Cohort 2: Treatment Sequence B-C-A, Cohort 3: Treatment Sequence C-A-B, Cohort 4: Treatment Sequence A-C-B, Cohort 5: Treatment Sequence C-B-A, Cohort 6: Treatment Sequence B-A-C

Primary outcome

Plasma Concentration of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 1 hour post-dose
Partial Area Under the Concentration Curve (AUC) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 1 hour post-dose

11 secondary outcomes

Area Under the Curve from Time 0 to the Last Measured Concentration (AUC0-t) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Percentage of AUC0-inf Obtained by Extrapolation (AUCextrap) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Last Quantifiable Concentration (Clast) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time of the Last Quantifiable Concentration (Tlast) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Time Prior to the First Measurable (Non-Zero) Concentration (Tlag) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Rate Constant (λz) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Elimination Half-Life (t1/2) of Unconjugated Naloxone
Time frame: Pre-dose and at multiple time points up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 10

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 1 Feb 2019.

Related trials for Healthy Volunteer

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

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.

Giovanni DeCastro study director

INSYS Therapeutics Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 10 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 1 Feb 2019. 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?

Plasma Concentration of Unconjugated Naloxone (time frame: Pre-dose and at multiple time points up to 1 hour post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03827629.

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 1 Feb 2019.