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Comparison of Naloxone Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT03386591
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Naloxone Device: Mucosal atomization device and syringe Device: Narcan Device: Intramuscular Auto Injector Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : February 8, 2018
Estimated Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mucosal Atomization (1 administration)
One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)
Drug: Naloxone
Comparing pharmacokinetics of naloxone
Device: Mucosal atomization device and syringe
Injection
Experimental: Mucosal Atomization (2 administrations)
Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart
Drug: Naloxone
Comparing pharmacokinetics of naloxone
Device: Mucosal atomization device and syringe
Injection
Experimental: Narcan 2mg
One Intranasal administration of 2 mg naloxone using Narcan nasal spray
Drug: Naloxone
Comparing pharmacokinetics of naloxone
Device: Narcan
Nasal Spray
Experimental: Narcan 4mg
One Intranasal administration of 4 mg naloxone using Narcan nasal spray
Drug: Naloxone
Comparing pharmacokinetics of naloxone
Device: Narcan
Nasal Spray
Experimental: Intramuscular auto injector
One Intramuscular administration of 2 mg naloxone using Evzio auto-injector
Drug: Naloxone
Comparing pharmacokinetics of naloxone
Device: Intramuscular Auto Injector
Intramuscular injection
Other Name: Evzio


Outcome Measures

Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: 11 days ]
    Maximum plasma concentration, observed by inspection of individual study participant plots of plasma concentration versus time

  2. Time of Maximum observed concentration (Tmax) [ Time Frame: 11 days ]
    Time of maximum observed concentration, obtained directly from the observed concentration versus time data

  3. Area under the concentration-time curve (AUC 0-t) [ Time Frame: 11 days ]
    The area under the concentration-time curve from time 0 (predose) to the time of last quantifiable concentration, calculated by the linear-up/log-down trapezoidal method.

  4. Area under the concentration-time curve (AUC 0-inf) [ Time Frame: 11 days ]
    Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC 0-t + C-last/ λz, where C-last is the observed last quantifiable concentration


Secondary Outcome Measures :
  1. Incidence of increased Vital Signs [ Time Frame: 16 days ]
    Number of participants with adverse events as assessed by vital signs

  2. Incidence of Increased ECG Reading [ Time Frame: 16 days ]
    Number of participants with adverse events as assessed by ECG

  3. Incidence of Clinically Significant Laboratory Values [ Time Frame: 16 days ]
    Number of participants with adverse events as assessed by laboratory changes

  4. Incidence of Nasal Irritation [ Time Frame: 16 days ]
    Number of participants with adverse events as assessed self report and physical inspection of nasal cavity


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females 18 to 55 years of age, inclusive
  • Provide written informed consent
  • BMI ranging from 18 to 32 kg/m2, inclusive
  • Adequate venous access
  • No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
  • Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
  • Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
  • Agree not to ingest alcohol, drinks containing xanthine >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

Exclusion Criteria:

  • Contact site directly for more information
Contacts and Locations

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): NCT03386591


Contacts
Contact: Debra Kelsh, MD (913) 696-1601 dkelsh@vinceandassociates.com
Contact: Debra Kelsh, MD (913) 696-1601

Locations
United States, Kansas
Vince and Associates Clinical Research Recruiting
Overland Park, Kansas, United States, 66212
Contact: Debra Kelsh, MD    913-696-1601    dkelsh@vinceandassociates.com   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Debra Kelsh, MD Vince and Associates Clinical Research
More Information

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03386591     History of Changes
Other Study ID Numbers: Naloxone P1a-003
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents