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Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

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ClinicalTrials.gov Identifier: NCT01761565
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : February 11, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Plasma Concentrations
Interventions Drug: Single dose of SUF NT 15 mcg
Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg
Hide Arm/Group Description

Arm 1/Period 1: Single dose of SUF NT 15 mcg

Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing

Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg

Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2.

Period Title: Single Dose of SUF NT 15 mcg
Started 40
Completed 40
Not Completed 0
Period Title: 40 Consecutive Doses of SUF 15 mcg
Started 39 [1]
Completed 38
Not Completed 1
Reason Not Completed
Adverse Event             1
[1]
Subject was withdrawn from the study prior to the second arm/period due to non-compliance
Arm/Group Title One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg
Hide Arm/Group Description

Arm 1/Period 1: Single dose of SUF NT 15 mcg

Single dose of SUF NT 15 mcg

Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg

40 consecutive doses of SUF NT 15 mcg

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
One patient was withdrawn after Period 1 due to non-compliance
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
19
  47.5%
Male
21
  52.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Cmax
Hide Description

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 Frame 24 hours in Treatment A, 37 hours in Treatment B
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Single Dose of SUF NT 15 mcg 40 Consecutive Doses of SUF NT 15 mcg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: pg/mL
34.96  (12.23) 249.55  (72.13)
2.Primary Outcome
Title Time to Steady State
Hide Description 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)
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title 40 Consecutive Doses of SUF NT 15 mcg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: hours
4
3.Primary Outcome
Title CST½
Hide Description the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Time Frame 24
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Single Dose of SUF NT 15 mcg 40 Consecutive Doses of SUF NT 15 mcg
Hide Arm/Group Description:
Arm 1/Period 1: Single dose of SUF NT 15 mcg
[Not Specified]
Overall Number of Participants Analyzed 38 38
Median (Full Range)
Unit of Measure: hours
2.17
(0.17 to 5.00)
2.66
(1.33 to 3.95)
Time Frame AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Dose of SUF NT 15 mcg 40 Consecutive Doses of SUF NT 15 mcg
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Single Dose of SUF NT 15 mcg 40 Consecutive Doses of SUF NT 15 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Single Dose of SUF NT 15 mcg 40 Consecutive Doses of SUF NT 15 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/39 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Single Dose of SUF NT 15 mcg 40 Consecutive Doses of SUF NT 15 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   5/40 (12.50%)   18/39 (46.15%) 
Cardiac disorders     
Palpitations * 1 [1]  0/40 (0.00%)  1/39 (2.56%) 
Eye disorders     
Photophobia * 1  0/40 (0.00%)  2/39 (5.13%) 
Gastrointestinal disorders     
Nausea * 1  1/40 (2.50%)  6/39 (15.38%) 
Abdominal Pain * 1  0/40 (0.00%)  2/39 (5.13%) 
Vomiting * 1  1/40 (2.50%)  1/39 (2.56%) 
Dry mouth * 1  0/40 (0.00%)  1/39 (2.56%) 
Dyspepsia * 1  0/40 (0.00%)  1/39 (2.56%) 
General disorders     
Feeling abnormal * 1  0/40 (0.00%)  1/39 (2.56%) 
Feeling jittery * 1  0/40 (0.00%)  1/39 (2.56%) 
Infections and infestations     
Upper respiratory tract infection * 1  1/40 (2.50%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain * 1  0/40 (0.00%)  1/39 (2.56%) 
Nervous system disorders     
Headache * 1  4/40 (10.00%)  6/39 (15.38%) 
Somnolence * 1  0/40 (0.00%)  4/39 (10.26%) 
Dizziness * 1  0/40 (0.00%)  3/39 (7.69%) 
Syncope vasovagal * 1  0/40 (0.00%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  0/40 (0.00%)  1/39 (2.56%) 
Vascular disorders     
Hot flush * 1  0/40 (0.00%)  3/39 (7.69%) 
Flushing * 1  0/40 (0.00%)  1/39 (2.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
[1]
All adverse events listed in the above table are included regardless of relationship to study drug
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must be able to review any publications prior to publication
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pamela Palmer, MD, PhD
Organization: AcelRx Pharmaceuticals, Inc.
Phone: 650-216-3504
EMail: ppalmer@acelrx.com
Layout table for additonal information
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01761565    
Other Study ID Numbers: IAP101
First Submitted: January 3, 2013
First Posted: January 7, 2013
Results First Submitted: December 15, 2014
Results First Posted: February 11, 2015
Last Update Posted: October 1, 2015