PharmacokineticsPhase 1NCT01639729

Effect of Delivery Route on PK of Sufentanil NanoTab

A Phase 1 study testing Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual and Treatment C: Sufentanil NanoTab Buccal in people with Pharmacokinetics, 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 whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual and Treatment C: Sufentanil NanoTab Buccal
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Jul 2012
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

body mass index 18 - 30

Who cannot join

pregnant females
smokers
pulmonary disease
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: Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Conditions: Pharmacokinetics
Being tested: Treatment A: Sufentanil IV, Treatment B: Sufentanil NanoTab Sublingual, Treatment C: Sufentanil NanoTab Buccal, Treatment D: Sufentanil NanoTab Oral
Keywords: pharmacokinetics, area under curve, time to maximum concentration

What participants receive

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

Treatment A: Sufentanil IVDrug
Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
Treatment B: Sufentanil NanoTab SublingualDrug
Single Sufentanil NanoTab 15 mcg given sublingually (SL)
Treatment C: Sufentanil NanoTab BuccalDrug
Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
Treatment D: Sufentanil NanoTab OralDrug
Single Sufentanil NanoTab 15 mcg swallowed (PO)

Study groups in NCT01639729
Study group	Role	What they receive
Sequence 1 - Treatment A, B, C, D	Experimental	15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral Receives: Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral
Sequence 2 - Treatment A, B, D, C	Experimental	15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal Receives: Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral
Sequence 3 - Treatment A, C, B, D	Experimental	15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral Receives: Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral
Sequence 4 - Treatment A, C, D, B	Experimental	15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual Receives: Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral
Sequence 5 - Treatment A, D, B, C	Experimental	15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal Receives: Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral
Sequence 6 - Treatment A, D, C, B	Experimental	15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual Receives: Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral

What is being measured

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

AUC (0 - Inf)
total amount of sufentanil absorbed
Measured: 24 hours
Cmax
maximum plasma concentration
Measured: 24 hours
Tmax
time to maximum plasma concentration
Measured: 24 hours
CST 1/2
time for maximum plasma concentration to decrease by 50%
Measured: 24 hours

Timeline

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

Jul 2012Jul 2012

First posted13 Jul 2012 (estimated)
Study startJul 2012
Primary completionJul 2012
Study completionJul 2012

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 PharmacokineticsStudies 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01639729
Sponsor's protocol ID: IAP102
Status last verified: Sep 2015
First submitted: 11 Jul 2012
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?

See locations

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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: Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects
ClinicalTrials.gov ID: NCT01639729
Acronym / sponsor ID: IAP102
Conditions: Pharmacokinetics
Keywords: pharmacokinetics, area under curve, time to maximum concentration
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Talphera, IncIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 13 Jul 2012 (estimated)
Results: Posted 21 May 2014

Clinical summary

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

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1 - Treatment A, B, C, D	Experimental	Drug: Treatment A: Sufentanil IV, Drug: Treatment B: Sufentanil NanoTab Sublingual, Drug: Treatment C: Sufentanil NanoTab Buccal, Drug: Treatment D: Sufentanil NanoTab Oral15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral
Sequence 2 - Treatment A, B, D, C	Experimental	Drug: Treatment A: Sufentanil IV, Drug: Treatment B: Sufentanil NanoTab Sublingual, Drug: Treatment C: Sufentanil NanoTab Buccal, Drug: Treatment D: Sufentanil NanoTab Oral15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal
Sequence 3 - Treatment A, C, B, D	Experimental	Drug: Treatment A: Sufentanil IV, Drug: Treatment B: Sufentanil NanoTab Sublingual, Drug: Treatment C: Sufentanil NanoTab Buccal, Drug: Treatment D: Sufentanil NanoTab Oral15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral
Sequence 4 - Treatment A, C, D, B	Experimental	Drug: Treatment A: Sufentanil IV, Drug: Treatment B: Sufentanil NanoTab Sublingual, Drug: Treatment C: Sufentanil NanoTab Buccal, Drug: Treatment D: Sufentanil NanoTab Oral15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual
Sequence 5 - Treatment A, D, B, C	Experimental	Drug: Treatment A: Sufentanil IV, Drug: Treatment B: Sufentanil NanoTab Sublingual, Drug: Treatment C: Sufentanil NanoTab Buccal, Drug: Treatment D: Sufentanil NanoTab Oral15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal
Sequence 6 - Treatment A, D, C, B	Experimental	Drug: Treatment A: Sufentanil IV, Drug: Treatment B: Sufentanil NanoTab Sublingual, Drug: Treatment C: Sufentanil NanoTab Buccal, Drug: Treatment D: Sufentanil NanoTab Oral15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual

Who may qualify

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

Key inclusion criteria (1 listed)

body mass index 18 - 30

Key exclusion criteria (4 listed)

pregnant females
smokers
pulmonary disease
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
Treatment A: Sufentanil IVSufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)	Drug	Sequence 1 - Treatment A, B, C, D, Sequence 2 - Treatment A, B, D, C, Sequence 3 - Treatment A, C, B, D, Sequence 4 - Treatment A, C, D, B, Sequence 5 - Treatment A, D, B, C, Sequence 6 - Treatment A, D, C, B
Treatment B: Sufentanil NanoTab SublingualSingle Sufentanil NanoTab 15 mcg given sublingually (SL)	Drug	Sequence 1 - Treatment A, B, C, D, Sequence 2 - Treatment A, B, D, C, Sequence 3 - Treatment A, C, B, D, Sequence 4 - Treatment A, C, D, B, Sequence 5 - Treatment A, D, B, C, Sequence 6 - Treatment A, D, C, B
Treatment C: Sufentanil NanoTab BuccalTreatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)	Drug	Sequence 1 - Treatment A, B, C, D, Sequence 2 - Treatment A, B, D, C, Sequence 3 - Treatment A, C, B, D, Sequence 4 - Treatment A, C, D, B, Sequence 5 - Treatment A, D, B, C, Sequence 6 - Treatment A, D, C, B
Treatment D: Sufentanil NanoTab OralSingle Sufentanil NanoTab 15 mcg swallowed (PO)	Drug	Sequence 1 - Treatment A, B, C, D, Sequence 2 - Treatment A, B, D, C, Sequence 3 - Treatment A, C, B, D, Sequence 4 - Treatment A, C, D, B, Sequence 5 - Treatment A, D, B, C, Sequence 6 - Treatment A, D, C, B

Primary outcome

AUC (0 - Inf)
Time frame: 24 hours
total amount of sufentanil absorbed
Cmax
Time frame: 24 hours
maximum plasma concentration
Tmax
Time frame: 24 hours
time to maximum plasma concentration
CST 1/2
Time frame: 24 hours
time for maximum plasma concentration to decrease by 50%

Results and safety

Results posted to the registry on 21 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Treatment A, B, C, D	4	3
Sequence 2: A, B, D, C	4	4
Sequence 3: Treatment A, C, B, D	4	3
Sequence 4: Treatment A, C, D, B	5	4
Sequence Five: Treatments A, D, B, C	4	4
Sequence 6: Treatments A, D, C, B	4	4

Primary outcome: AUC (0 - Inf)

Time frame: 24 hours. Mean (Standard Deviation). Unit: h.pg/mL

Measure	Sufentanil IV n = 22	Sufentanil NanoTab Buccal n = 22	Sufentanil NanoTab Sublingual n = 22	Sufentanil NanoTab Oral n = 18
Value	273.8 (61.1)	212.5 (57.0)	163.4 (52.5)	24.9 (14.1)

Population analysed: A The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: AUC 0-inf (n=18).

Primary outcome: Cmax

Time frame: 24 hours. Mean (Standard Deviation). Unit: pg/mL

Measure	Sufentanil IV n = 22	Sufentanil NanoTab Buccal n = 22	Sufentanil NanoTab Sublingual n = 22	Sufentanil NanoTab Oral n = 22
Value	445.1 (312.0)	58.9 (25.7)	40.6 (14.8)	4.3 (3.8)

Primary outcome: Tmax

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

Measure	Sufentanil IV n = 22	Sufentanil NanoTab Buccal n = 22	Sufentanil NanoTab Sublingual n = 22	Sufentanil NanoTab Oral n = 22
Value	0.07 (0.02 to 0.12)	0.85 (0.67 to 2.07)	0.83 (0.33 to 1.50)	1.11 (0.67 to 3.00)

Primary outcome: CST 1/2

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

Measure	Sufentanil IV n = 22	Sufentanil NanoTab Buccal n = 22	Sufentanil NanoTab Sublingual n = 22	Sufentanil NanoTab Oral n = 16
Value	0.14 (0.05 to 0.68)	2.28 (0.13 to 4.67)	2.50 (1.50 to 4.83)	2.00 (0.83 to 4.67)

Population analysed: The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: CST½ (n=16).

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sufentanil IV	0 of 25 (0%)	8 of 25 (32%)	Not reported
Sufentanil NanoTab Buccal	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Sufentanil NanoTab Sublingual	0 of 24 (0%)	5 of 24 (20.8%)	Not reported
Sufentanil NanoTab Oral	0 of 23 (0%)	3 of 23 (13%)	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.

Pamela Palmer, M.D. study director

Talphera, Inc

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 1 inclusion and 4 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 21 May 2014). 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?

AUC (0 - Inf) (time frame: 24 hours). The study lists 4 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 NCT01639729, 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.