Effect of Delivery Route on PK of Sufentanil NanoTab

NCT01639729 | Completed Phase 1 Results

• 1 other identifier: IAP102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics

Keywords

pharmacokinetics; area under curve; time to maximum concentration

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (6)

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; 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

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

Drug: Treatment A: Sufentanil IV; Drug: Treatment B: Sufentanil NanoTab Sublingual; Drug: Treatment C: Sufentanil NanoTab Buccal; Drug: Treatment D: Sufentanil NanoTab Oral

Interventions

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; 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 Sublingual DRUG

Single Sufentanil NanoTab 15 mcg given sublingually (SL)

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 Buccal DRUG

Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)

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 Oral DRUG

Single Sufentanil NanoTab 15 mcg swallowed (PO)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index 18 - 30

You may not qualify if:

• pregnant females
• smokers
• pulmonary disease
• sleep apnea

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (1)

PRA

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

• 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.

  PMID: 25544247 BACKGROUND

Results Point of Contact

• Title: Pamela Palmer
• Organization: AcelRx

ppalmer@acelrx.com

650-216-3500

Study Officials

• Pamela Palmer, M.D.

  Talphera, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 1, 2015
• Results First Posted: May 21, 2014

Record last verified: 2015-09

Locations

US (1)