Trial Outcomes & Findings for Effect of Delivery Route on PK of Sufentanil NanoTab (NCT NCT01639729)
NCT ID: NCT01639729
Last Updated: 2015-10-01
Results Overview
total amount of sufentanil absorbed
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
24 hours
Results posted on
2015-10-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Delivery Route on PK of Sufentanil NanoTab
Baseline characteristics by cohort
| Measure |
Treatment A, Followed by Treatment B, C and D in Random Order
n=25 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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).
total amount of sufentanil absorbed
Outcome measures
| Measure |
Sufentanil IV
n=22 Participants
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.
|
Sufentanil NanoTab Buccal
n=22 Participants
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.
|
Sufentanil NanoTab Sublingual
n=22 Participants
Sufentanil : 15 mcg sublingual
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.
|
Sufentanil NanoTab Oral
n=18 Participants
Sufentanil : 15 mcg oral
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.
|
|---|---|---|---|---|
|
AUC (0 - Inf)
|
273.8 h.pg/mL
Standard Deviation 61.1
|
212.5 h.pg/mL
Standard Deviation 57.0
|
163.4 h.pg/mL
Standard Deviation 52.5
|
24.9 h.pg/mL
Standard Deviation 14.1
|
PRIMARY outcome
Timeframe: 24 hoursmaximum plasma concentration
Outcome measures
| Measure |
Sufentanil IV
n=22 Participants
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.
|
Sufentanil NanoTab Buccal
n=22 Participants
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.
|
Sufentanil NanoTab Sublingual
n=22 Participants
Sufentanil : 15 mcg sublingual
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.
|
Sufentanil NanoTab Oral
n=22 Participants
Sufentanil : 15 mcg oral
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.
|
|---|---|---|---|---|
|
Cmax
|
445.1 pg/mL
Standard Deviation 312.0
|
58.9 pg/mL
Standard Deviation 25.7
|
40.6 pg/mL
Standard Deviation 14.8
|
4.3 pg/mL
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: 24 hourstime to maximum plasma concentration
Outcome measures
| Measure |
Sufentanil IV
n=22 Participants
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.
|
Sufentanil NanoTab Buccal
n=22 Participants
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.
|
Sufentanil NanoTab Sublingual
n=22 Participants
Sufentanil : 15 mcg sublingual
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.
|
Sufentanil NanoTab Oral
n=22 Participants
Sufentanil : 15 mcg oral
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.
|
|---|---|---|---|---|
|
Tmax
|
0.07 hours
Interval 0.02 to 0.12
|
0.85 hours
Interval 0.67 to 2.07
|
0.83 hours
Interval 0.33 to 1.5
|
1.11 hours
Interval 0.67 to 3.0
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: CST½ (n=16).
time for maximum plasma concentration to decrease by 50%
Outcome measures
| Measure |
Sufentanil IV
n=22 Participants
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.
|
Sufentanil NanoTab Buccal
n=22 Participants
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.
|
Sufentanil NanoTab Sublingual
n=22 Participants
Sufentanil : 15 mcg sublingual
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.
|
Sufentanil NanoTab Oral
n=16 Participants
Sufentanil : 15 mcg oral
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.
|
|---|---|---|---|---|
|
CST 1/2
|
0.14 hours
Interval 0.05 to 0.68
|
2.28 hours
Interval 0.13 to 4.67
|
2.50 hours
Interval 1.5 to 4.83
|
2.00 hours
Interval 0.83 to 4.67
|
Adverse Events
Sufentanil IV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sufentanil NanoTab Buccal
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sufentanil NanoTab Sublingual
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sufentanil NanoTab Oral
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sufentanil IV
n=25 participants at risk
Sufentanil : 15 mcg IV
|
Sufentanil NanoTab Buccal
n=24 participants at risk
Sufentanil : 15 mcg buccal
|
Sufentanil NanoTab Sublingual
n=24 participants at risk
Sufentanil : 15 mcg sublingaul
|
Sufentanil NanoTab Oral
n=23 participants at risk
Sufentanil : 15 mcg oral
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
16.0%
4/25
|
4.2%
1/24
|
0.00%
0/24
|
8.7%
2/23
|
|
Nervous system disorders
headache
|
8.0%
2/25
|
8.3%
2/24
|
4.2%
1/24
|
0.00%
0/23
|
|
Eye disorders
photophobia
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
abdominal pain
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
4.3%
1/23
|
|
Gastrointestinal disorders
hypoaesthesia oral
|
0.00%
0/25
|
4.2%
1/24
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
paraesthesia oral
|
0.00%
0/25
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
4.3%
1/23
|
|
General disorders
fatigue
|
0.00%
0/25
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
decreased appetite
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/25
|
0.00%
0/24
|
4.2%
1/24
|
0.00%
0/23
|
|
Psychiatric disorders
flat effect
|
4.0%
1/25
|
4.2%
1/24
|
4.2%
1/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
infusion site pain
|
4.0%
1/25
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
dizziness
|
0.00%
0/25
|
0.00%
0/24
|
0.00%
0/24
|
4.3%
1/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee requires prior approval
- Publication restrictions are in place
Restriction type: OTHER