Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Opioid-Related Disorders

Treatments: Other: Intravail; Drug: Naltrexone

Study type: Interventional

Funder types: NIH

Identifiers

NCT02750748

Naltexone-Ph1a-002

Details and patient eligibility

About

To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females 18 to 55 years of age, inclusive.
• Provide written informed consent.
• 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.
• Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 4 patient groups

4mg Intranasal Naltrexone

Experimental group

Description:

Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril

Treatment:

Drug: Naltrexone

4mg Intranasal Naltrexone with Intravail

Experimental group

Description:

Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril

Treatment:

Drug: Naltrexone

Other: Intravail

2mg Intramuscular Naltrexone

Experimental group

Description:

Administer 2 mg formulation intramuscularly

Treatment:

Drug: Naltrexone

50mg Naltrexone

Experimental group

Description:

Administer 50mg formulation orally

Treatment:

Drug: Naltrexone