Plasma Concentrations
Conditions
Brief summary
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs
Interventions
DRUGSingle dose of SUF NT 15 mcg
DRUG40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Sponsors
Talphera, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Non smoking * Ages 18 to 45 year, inclusive * BMI between 18 and 30
Exclusion criteria
* Subjects taking any prescription or OTC medications or vitamins or supplements * Pregnant females * Subjects with pulmonary disease or sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 24 hours in Treatment A, 37 hours in Treatment B | 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 to Steady State | 24 hours | 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) |
| CST½ | 24 | the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg 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 | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 40 Consecutive Doses of SUF 15 mcg | Adverse Event | 1 |
Baseline characteristics
| Characteristic | One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 40 | 18 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 |
Outcome results
Primary
Cmax
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
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Dose of SUF NT 15 mcg | Cmax | 34.96 pg/mL | Standard Deviation 12.23 |
| 40 Consecutive Doses of SUF NT 15 mcg | Cmax | 249.55 pg/mL | Standard Deviation 72.13 |
Primary
CST½
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Dose of SUF NT 15 mcg | CST½ | 2.17 hours |
| 40 Consecutive Doses of SUF NT 15 mcg | CST½ | 2.66 hours |
Primary
Time to Steady State
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
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Dose of SUF NT 15 mcg | Time to Steady State | 4 hours |