Effect of Delivery Route on PK of Sufentanil NanoTab | NCT01639729

NCT01639729

Protocol Section

Identification Module

Results Section

Participant Flow Module

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

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1 - Treatment A, B, C, D	Experimental	15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral	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	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	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	Drug: Treatment A: Sufentanil IV Drug: Treatment B: Sufentanil NanoTab Sublingual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment A: Sufentanil IV	Drug	Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)	Sequence 1 - Treatment A, B, C, D Sequence 2 - Treatment A, B, D, C

Outcomes Module

Primary Outcomes

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

Eligibility Module

Name	Affiliation	Role
Pamela Palmer, M.D.	Talphera, Inc	Study Director

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25544247	Background	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.

Arm/Group Information

ID	Title	Description
FG000	Sequence 1: Treatment A, B, C, D	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing.
FG001	Sequence 2: A, B, D, C	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing.
FG002	Sequence 3: Treatment A, C, B, D	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing.
FG003	Sequence 4: Treatment A, C, D, B	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing.
FG004	Sequence Five: Treatments A, D, B, C	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing.
FG005	Sequence 6: Treatments A, D, C, B	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0004 subjects FG0014 subjects FG0024 subjects FG0035 subjects FG0044 subjects FG0054 subjects
COMPLETED		FG0003 subjects FG0014 subjects FG0023 subjects FG0034 subjects FG004
NOT COMPLETED		FG0001 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0010 subjects FG0021 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Treatment A, Followed by Treatment B, C and D in Random Order	Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) Sequence 1: A, B, C, D Sequence 2: A, B, D, C Sequence 3: A, C, B, D Sequence 4: A, C, D, B Sequence 5: A, D, B, C Sequence 6: A, D, C, B A 48-hour washout period separated each treatment period. The washout began with the start of dosing.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

AUC (0 - Inf)

total amount of sufentanil absorbed

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).

Posted

Mean

Standard Deviation

h.pg/mL

24 hours

ID	Title	Description
OG000	Sufentanil IV	Sufentanil : 15 mcg IV PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing.
OG001	Sufentanil NanoTab Buccal	Sufentanil : 15 mcg buccal PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing.

Adverse Events Module