Phase 1
Completed N=7
A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
Source: ClinicalTrials.gov NCT02679469 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax) — 8.88 ng/mL
Summary
The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax) |
8.88 | — |
| PRIMARY Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt) |
61.8 | — |
| PRIMARY Measure the Terminal-phase Elimination Half-life (T1/2) |
12.1 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is a Japanese male.
- The subject is able to read and understand the informed consent form (ICF).
- The subject has a body mass index (BMI) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening visit.
- The subject has a resting pulse and heart rate (as read on the ECG) ≥ 45 bpm and ≤ 100 bpm at the screening visit.
Exclusion Criteria
- The subject has taken any prescription drugs, over-the counter medications, vitamin supplements, or supplements containing St. John's Wort (Hypericum perforatum) within 2 weeks prior to Day 1.
- The subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week. (A unit of alcohol is defined as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits.)
- The subject has taken any investigational products within 4 months prior to Day 1.
Data sourced from ClinicalTrials.gov (NCT02679469). 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.