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CompletedNCT02082236Updated Jul 17, 2018

Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

A Phase 1 interventional study of Treatment Arm A: Sufenta® and Treatment B: Sufentanil SSM 30 mcg in Healthy, sponsored by Talphera, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-17.

Sponsored by Talphera, Inc · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.

02

Conditions studied

  • Healthy

Keywords

  • Plasma concentrations
03

In context

Lead sponsor

Talphera, Inc is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Non-smoking male or female subjects
  2. Aged between 18 and 45 years inclusive
  3. Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
  2. Female subjects who are pregnant
  3. Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Treatment A

    Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute

    Drug: Treatment Arm A: Sufenta®

  • Experimental
    Treatment B

    Single dose of SSM 30 mcg

    Drug: Treatment B: Sufentanil SSM 30 mcg

  • Experimental
    Treatment C

    2 consecutive doses of SSM 15 mcg administered 20 minute apart

    Drug: Treatment C: SSM 15 mcg

  • Experimental
    Treatment D

    12 consecutive doses of SSM 30 mcg administered 1 hour apart

    Drug: Treatment D: SSM 30 mcg

Interventions

  • DrugTreatment Arm A: Sufenta®

    Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute

  • DrugTreatment B: Sufentanil SSM 30 mcg

    single-dose SSM 30 mcg

  • DrugTreatment C: SSM 15 mcg

    2 consecutive doses of SSM 15 mcg administered 20 minutes apart

  • DrugTreatment D: SSM 30 mcg

    12 consecutive doses of SSM 30 mcg administered 1 hour apart

06

What researchers measure

Primary outcomes

  1. Area Under the Curve

    Area under the plasma concentration time curve

    Time frame: 9 days, not including a 30 day screening window

Other outcomes

  1. C max

    Maximum plasma concentration

    Time frame: 9 days

  2. T max

    Time to reach maximum plasma concentration

    Time frame: 9 days

  3. Context Sensitive Half-Time (CST½)

    Time frame: 9 hours

07

Study locations

1 site
  • PRA
    Lenexa, Kansas 66219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02082236
Lead sponsor
Talphera, Inc
Responsible party
Sponsor
First posted
Mar 10, 2014
Start date
May 2014
Primary completion
May 2014
Completion
May 2014
Last update
Jul 17, 2018

Study contacts

Sandra K. Willsie, D.O.
principal investigator · PRA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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