Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Phase 1

Completed

• Conditions: Plasma Concentrations
• Interventions: Drug: Single dose of SUF NT 15 mcg; Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

• Registration Number: NCT01761565
• Lead Sponsor: Talphera, Inc

Brief Summary

Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-12-15
• Results First Submitted QC: 2015-01-26
• Results First Posted: 2015-02-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg	Single dose 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
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg	40 consecutive doses of SUF NT 15 mcg taken every 20 minutes	Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Primary Outcome Measures

Name	Time	Method
Cmax	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	24	the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Time to Steady State	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)

Trial Locations

Locations (1)

PRA; 🇺🇸 Lenexa, Kansas, United States