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

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ClinicalTrials.gov Identifier: NCT03827629
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Treatment A: Naloxone Nasal Spray Drug: Treatment B: Naloxone Nasal Spray Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Randomized, Crossover, Comparative Bioavailability Study of Naloxone Nasal Spray and Naloxone Hydrochloride Intramuscular Injection in Healthy Volunteers
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: Treatment Sequence A-B-C
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.
 Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Experimental: Cohort 2: Treatment Sequence B-C-A
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.
 Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Experimental: Cohort 3: Treatment Sequence C-A-B
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.
 Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Experimental: Cohort 4: Treatment Sequence A-C-B
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.
 Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Experimental: Cohort 5: Treatment Sequence C-B-A
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.
 Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Experimental: Cohort 6: Treatment Sequence B-A-C
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.
 Drug: Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.

Drug: Treatment C: Naloxone HCL Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Concentration of Unconjugated Naloxone [ Time Frame: Pre-dose and at multiple time points up to 1 hour post-dose ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Maximum Plasma Concentration (Cmax) of Unconjugated Naloxone [ Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose ]
  5. 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 ]
  6. Last Quantifiable Concentration (Clast) of Unconjugated Naloxone [ Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose ]
  7. 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 ]
  8. 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 ]
  9. Elimination Rate Constant (λz) of Unconjugated Naloxone [ Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose ]
  10. Elimination Half-Life (t1/2) of Unconjugated Naloxone [ Time Frame: Pre-dose and at multiple time points up to 24 hours post-dose ]
  11. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 10 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827629


Locations
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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Giovanni DeCastro INSYS Therapeutics Inc
More Information
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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03827629    
Other Study ID Numbers: INS012-17-108
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents