Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single dose of SUF NT · 1 trial · 1 indication
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
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)
the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration
| Arm | Type | Description |
|---|---|---|
| Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg | EXPERIMENTAL | Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes |
| Name | Type | Description |
|---|---|---|
| Single dose of SUF NT 15 mcg | DRUG | - |
| 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | DRUG | - |
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
SUF NT is a small molecule drug being developed by Talphera, Inc. for use in measuring plasma concentrations. It is currently in Phase 1 clinical development as an investigational product, meaning it is not yet approved for any medical use.
The molecular target of SUF NT has not been disclosed. The drug is being studied for its pharmacokinetic properties, specifically how it is absorbed and distributed in the body, as measured by plasma concentrations.
SUF NT is being developed by Talphera, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and safety profile.
SUF NT is in Phase 1 clinical development. A Phase 1 study has been completed, which focused on evaluating the drug's pharmacokinetics after single and multiple doses. The drug remains investigational and has not been approved by regulatory authorities.
SUF NT has one completed Phase 1 clinical trial, identified as NCT01761565. This study, titled 'Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab', enrolled 40 healthy volunteers in the United States and was not randomized or blinded.
Yes, SUF NT is also known as Sufentanil NanoTab. The completed clinical trial NCT01761565 evaluated the pharmacokinetics of Sufentanil NanoTab, which is the same drug product referred to as SUF NT.