Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Talphera, Inc
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non smoking
- •Ages 18 to 45 year, inclusive
- •BMI between 18 and 30
Exclusion Criteria
- •Subjects taking any prescription or OTC medications or vitamins or supplements
- •Pregnant females
- •Subjects with pulmonary disease or sleep apnea
Arms & Interventions
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
Period 1: Single dose of SUF NT 15 mcg
Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Intervention: Single dose of SUF NT 15 mcg (Drug)
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
Period 1: Single dose of SUF NT 15 mcg
Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Intervention: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: 24 hours in Treatment A, 37 hours in Treatment B
For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3
CST½
Time Frame: 24
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Time to Steady State
Time Frame: 24 hours
Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p \>0.05)
Secondary Outcomes
No secondary outcomes reported