Plasma ConcentrationsPhase 1NCT01761565

Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

A Phase 1 study testing Single dose of SUF NT 15 mcg and 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes in people with Plasma Concentrations, run by Talphera, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Plasma Concentrations
What is being tested?: Single dose of SUF NT 15 mcg and 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Feb 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Non smoking
Ages 18 to 45 year, inclusive
BMI between 18 and 30

Who cannot join

Subjects taking any prescription or OTC medications or vitamins or supplements
Pregnant females
Subjects with pulmonary disease or sleep apnea

Trial locations and contacts

1 site in 1 country.

United States1 site

PRA
Lenexa, Kansas, 66219

Other trials in United States

About this study

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

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

Conditions: Plasma Concentrations
Being tested: Single dose of SUF NT 15 mcg, 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single dose of SUF NT 15 mcgDrug
40 consecutive doses of SUF NT 15 mcg taken every 20 minutesDrug
Also called Zalviso™

Study groups in NCT01761565
Study group	Role	What they receive
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 Receives: Drug: Single dose of SUF NT 15 mcg; Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
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
Measured: 24 hours in Treatment A, 37 hours in Treatment B
Time to Steady State
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)
Measured: 24 hours
CST½
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Measured: 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Feb 2013

First posted7 Jan 2013 (estimated)
Study startJan 2013
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Plasma ConcentrationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01761565
Sponsor's protocol ID: IAP101
Status last verified: Sep 2015
First submitted: 3 Jan 2013
Last updated: 1 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24.
PubMed 25544247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects
ClinicalTrials.gov ID: NCT01761565
Acronym / sponsor ID: IAP101
Conditions: Plasma Concentrations
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Talphera, IncIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 7 Jan 2013 (estimated)
Results: Posted 11 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg	Experimental	Drug: Single dose of SUF NT 15 mcg, Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutesPeriod 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Non smoking
Ages 18 to 45 year, inclusive
BMI between 18 and 30

Key exclusion criteria (3 listed)

Subjects taking any prescription or OTC medications or vitamins or supplements
Pregnant females
Subjects with pulmonary disease or sleep apnea

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single dose of SUF NT 15 mcg	Drug	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 minutesAlso: Zalviso™	Drug	Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg

Primary outcome

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
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)
CST½
Time frame: 24
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration

Results and safety

Results posted to the registry on 11 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg	40	40

Primary outcome: Cmax

Time frame: 24 hours in Treatment A, 37 hours in Treatment B. Mean (Standard Deviation). Unit: pg/mL

Measure	Single Dose of SUF NT 15 mcg n = 38	40 Consecutive Doses of SUF NT 15 mcg n = 38
Value	34.96 (12.23)	249.55 (72.13)

Population analysed: 2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)

Primary outcome: Time to Steady State

Time frame: 24 hours. Number. Unit: hours

Measure	40 Consecutive Doses of SUF NT 15 mcg n = 38
Value	4

Population analysed: 2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)

Primary outcome: CST½

Time frame: 24. Median (Full Range). Unit: hours

Measure	Single Dose of SUF NT 15 mcg n = 38	40 Consecutive Doses of SUF NT 15 mcg n = 38
Value	2.17 (0.17 to 5.00)	2.66 (1.33 to 3.95)

Population analysed: 2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)

Adverse events

Time frame: AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Dose of SUF NT 15 mcg	0 of 40 (0%)	5 of 40 (12.5%)	Not reported
40 Consecutive Doses of SUF NT 15 mcg	0 of 39 (0%)	18 of 39 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25544247Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sandra K. Willsie, D.O. principal investigator

PRA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 24 hours in Treatment A, 37 hours in Treatment B). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01761565, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.