Drug Overdose, Opioid-Related Disorders
Conditions
Brief 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. 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.
Interventions
DRUGNaloxone
Sponsors
Vince & Associates Clinical Research, Inc.
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Please contact clinical site directly for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Half-life | 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 |
| Maximum Plasma Concentration (Cmax) | 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) | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | minimum of 18 days | will be reported from the start of the first session to the follow-up visit |
| Vital Signs | 480 minutes | Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration. |
| 12-lead electrocardiogram | 480 minutes | Measured at pre-dose and at times 60 and 480 minutes after naloxone administration. |
| Nasal Irritation Scoring | 24 hours | Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration. |
Countries
United States
Outcome results
None listed