Phase 1
Completed N=68
Pharmacokinetic Evaluation of Intranasal Nalmefene
Pharmacokinetics
Source: ClinicalTrials.gov NCT04759768 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 12.2; 1.77 ng/ml
Summary
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
12.2; 1.77 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) |
0.25; 0.333 | — |
| PRIMARY Area Under the Curve (AUC-inf) |
41.5; 17.0 | — |
| PRIMARY Half-life (t1/2) |
11.4; 10.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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
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 over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
- Use of enzyme altering drugs 30 days before intervention
- Use of nasal products 28 days before intervention and throughout the study
- Previous or current opioid, alcohol, or other drug dependence
- Donated or received blood 30 days before intervention
- Women who are pregnant or breastfeeding at screening
- Women of childbearing potential unless surgically sterile or use effective contraception
- Current or recent upper respiratory tract infection
- Allergic to nalmefene
Data sourced from ClinicalTrials.gov (NCT04759768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.