Opioid-use Disorder
Conditions
Brief summary
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
Interventions
DRUGNaltrexone
Intranasal spray
DRUGNaloxone
Intranasal spray
DRUGNaltrexol
Intranasal spray
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females 18 to 55 years of age, inclusive. * Provide written informed consent. * Body mass index (BMI) ranging from 18 to 30 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. * 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. * Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, tea, coffee, 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 for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter [maximum serum concentration - Cmax] | 12 days | The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration \[Cmax\], of naltrexone and naloxone when administered and in combination. |
| Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t] | 12 days | The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve \[AUCO-t\] of naltrexone and naloxone when administered and in combination. |
| Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf] | 12 days | The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity \[AUCO-inf\] of naltrexone and naloxone when administered and in combination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital Sign - Blood pressure (systolic) | 12 days | To assess and document blood pressure (systolic) before and after intranasal dosing |
| Adverse Events | 15 days | To assess and document any adverse events measures |
| Electrocardiogram | 12 days | Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval. |
| Vital Sign - Respiration Rate | 12 days | To assess and document respiration rate before and after intranasal dosing |
| Vital Sign - Heart Rate | 12 days | To assess and document heart rate before and after intranasal dosing |
| Vital Sign - Blood pressure (diastolic) | 12 days | To assess and document blood pressure (diastolic) before and after intranasal dosing |
Outcome results
None listed