Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/30/-0001 |
| Start Date: | September 2013 |
| Contact: | Bradly D Vince, DO |
| Phone: | 913-696-1601 |
To determine the pharmacokinetics of 2 Intranasal doses (2 mg and 4 mg) 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. Also, to determine the safety of Intranasal naloxone, specifically with respect to
nasal irritation (erythema, edema, and erosion).
Inclusion Criteria:
- Males and females 18 to 55 years of age.
- Provide written informed consent.
- Body mass index (BMI) ranging from 18 to 30 kg/m2.
- 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. Note, 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:
- Please contact site for more information
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