Evaluation of Intranasal Naltrexone and Naloxone

• Status: Completed
• Trial end date: 2015-11-07
• Target enrollment: 0
• Participant gender: All

Summary

This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Naloxone; Naltrexone

Criteria

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:

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