Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens

Exclusion Criteria

• •History of clinically significant disease
• •Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
• •Following an abnormal diet 4 weeks prior to screening
• •Use of prescribed or over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention and throughout the study
• •Use of enzyme altering drugs 30 days before intervention or during the study
• •Use of nasal products 28 days before intervention and throughout the study
• •Experimental agents used at least 8 weeks prior to initial dosing for a period equivalent to 5 half-lives of the agent (whichever was longer).
• •Positive urine drug test for alcohol, opioids, cocaine, methamphetamine, benzodiazepines, tetrahydrocannabinol (THC), barbiturates, or methadone at screening or admission.
• •Previous or current opioid, alcohol, or other drug dependence (excluding nicotine and caffeine)
• •Positive urine screen for cotinine (smoking and the use of tobacco products were not permitted for 4 weeks prior to the first dose of study drug and throughout the duration of the study).
• •An ECG QTcF interval \>450 msec for males and \> or equal to 470 msec for females.
• •Clinically significant concurrent medical conditions
• •Donated or received blood 30 days before intervention
• •Women who are pregnant or breastfeeding at screening and prior to each administration of study drug
• •Women of childbearing potential unless surgically sterile or use effective contraception
• •Male subjects of childbearing potential that do not agree to use effective contraception
• •Male subjects who plan to donate sperm or have female partner(s) who are pregnant, lactating or planning to attempt to become pregnant during the study or within 4 weeks after completion of the study
• •Positive test for HBsAg, HCVAb, or HIVAb at screening
• •Current or recent upper respiratory tract infection
• •Current or recent use of any decongestants
• •Allergic to nalmefene
• •Those who would not abstain from engaging in strenuous exercise during the inpatient stay of the study.
• •Those who would not abstain from consuming poppy seed or similar opium derived food stuff during the study.
• •Those who would not abstain from ingesting alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice 72 hours before initial dosing and throughout the duration of the study.
• •Those deemed unlikely to be able to comply with the requirements of the protocol.
• •Those with any laboratory tests from samples taken at screening considered clinically significant.
• •Those with a known intolerance to continuous ECG lead adhesive exposure.
• •Brief Smell Identification Test (BSIT) score \< 5 at screening.
• •Those with a known hypersensitivity reaction to plastic.