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

National Institutes of Health (NIH) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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