Trial Outcomes & Findings for Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab (NCT NCT01761565)

Last Updated: 2015-10-01

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

24 hours in Treatment A, 37 hours in Treatment B

Results posted on

2015-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg 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.
Single Dose of SUF NT 15 mcg STARTED	40
Single Dose of SUF NT 15 mcg COMPLETED	40
Single Dose of SUF NT 15 mcg NOT COMPLETED	0
40 Consecutive Doses of SUF 15 mcg STARTED	39
40 Consecutive Doses of SUF 15 mcg COMPLETED	38
40 Consecutive Doses of SUF 15 mcg NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg 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.
40 Consecutive Doses of SUF 15 mcg Adverse Event	1

Baseline Characteristics

Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg n=40 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours in Treatment A, 37 hours in Treatment B

Population: 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)

Outcome measures

Outcome measures
Measure	Single Dose of SUF NT 15 mcg n=38 Participants	40 Consecutive Doses of SUF NT 15 mcg n=38 Participants
Cmax	34.96 pg/mL Standard Deviation 12.23	249.55 pg/mL Standard Deviation 72.13

PRIMARY outcome

Timeframe: 24 hours

Population: 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)

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)

Outcome measures

Outcome measures
Measure	Single Dose of SUF NT 15 mcg n=38 Participants	40 Consecutive Doses of SUF NT 15 mcg
Time to Steady State	4 hours	—

PRIMARY outcome

Timeframe: 24

Population: 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)

the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration

Outcome measures

Outcome measures
Measure	Single Dose of SUF NT 15 mcg n=38 Participants	40 Consecutive Doses of SUF NT 15 mcg n=38 Participants
CST½	2.17 hours Interval 0.17 to 5.0	2.66 hours Interval 1.33 to 3.95

Adverse Events

Single Dose of SUF NT 15 mcg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

40 Consecutive Doses of SUF NT 15 mcg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pamela Palmer, MD, PhD

AcelRx Pharmaceuticals, Inc.

Phone: 650-216-3504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must be able to review any publications prior to publication
Publication restrictions are in place

Restriction type: OTHER

Measure	Single Dose of SUF NT 15 mcg n=40 participants at risk	40 Consecutive Doses of SUF NT 15 mcg n=39 participants at risk
Eye disorders Photophobia	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	5.1% 2/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Gastrointestinal disorders Nausea	2.5% 1/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	15.4% 6/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Gastrointestinal disorders Abdominal Pain	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	5.1% 2/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Gastrointestinal disorders Vomiting	2.5% 1/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Gastrointestinal disorders Dry mouth	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Gastrointestinal disorders Dyspepsia	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
General disorders Feeling abnormal	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
General disorders Feeling jittery	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Infections and infestations Upper respiratory tract infection	2.5% 1/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	0.00% 0/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Nervous system disorders Headache	10.0% 4/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	15.4% 6/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Nervous system disorders Somnolence	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	10.3% 4/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Nervous system disorders Dizziness	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	7.7% 3/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Nervous system disorders Syncope vasovagal	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Vascular disorders Hot flush	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	7.7% 3/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Vascular disorders Flushing	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.
Cardiac disorders Palpitations	0.00% 0/40 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.	2.6% 1/39 • AEs were collected from administration of the first dose of study drug through completion of the post-treatment procedures.