Status:
COMPLETED
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
Lead Sponsor:
Opiant Pharmaceuticals Inc
Conditions:
Opioid Overdose
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a sing...
Detailed Description
Open-label, randomized, 3-period, 3-treatment, 6-sequence, ranodmised crossover study in 24 healthy volunteers. Subjects will be assigned to each of the 6 possible sequences. Each subject will receive...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 55 years inclusive
- BMI ranging from 18 to 30 kg/m2, inclusive
- Adequate venous access
- Subjects must be non-smokers
- On screening and admission, the following standards had to be met before dosing and were permitted to be repeated once:
- Systolic blood pressure: 140 mmHg or less and equal to or greater than 90 mmHg
- Diastolic blood pressure: 90 mmHg or less and equal to or greater than 55 mmHg
- Heart rate: 100 beats per minute (bpm) or less and equal to or greater than 40 bpm
- Respiratory rate: 20 respirations per minute (rpm) or less and equal to or greater than 8 rpm
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05219669
Start Date
September 1 2021
End Date
November 22 2021
Last Update
August 5 2024
Active Locations (1)
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1
WorldWide Clinical Trials
San Antonio, Texas, United States, 78217