Pharmacokinetics of Sufentanil Sublingual Microtablet 30... | NCT02082236

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

NCT02082236

Sponsor

Talphera, Inc

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Treatment Arm A: Sufenta®
Treatment B: Sufentanil SSM 30 mcg
Treatment C: SSM 15 mcg
Treatment D: SSM 30 mcg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Mar 6, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Active Comparator	Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute	Drug: Treatment Arm A: Sufenta®
Treatment B	Experimental	Single dose of SSM 30 mcg	Drug: Treatment B: Sufentanil SSM 30 mcg
Treatment C	Experimental	2 consecutive doses of SSM 15 mcg administered 20 minute apart	Drug: Treatment C: SSM 15 mcg
Treatment D	Experimental	12 consecutive doses of SSM 30 mcg administered 1 hour apart	Drug: Treatment D: SSM 30 mcg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment Arm A: Sufenta®	Drug	Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve	Area under the plasma concentration time curve	9 days, not including a 30 day screening window

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
C max	Maximum plasma concentration	9 days
T max	Time to reach maximum plasma concentration	9 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Female subjects who are pregnant
Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra K. Willsie, D.O.	PRA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRA		Lenexa	Kansas	66219	United States