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Clinical Trials/NCT01761565
NCT01761565CompletedPhase 1

Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects

Talphera, Inc1 site in 1 country40 target enrollmentStarted: January 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Experimental

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

Experimental

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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