Screening
How many subjects do we need to enroll in total?
36
During dosing, there are two timepoints in which you do not have a window for any assessments. What timepoints are they?
-30 and -5 Timepoint
If subject reports more than mild nausea or start to retch should be moved from a semi-recumbent to a ________ position.
lateral recumbent position (So if they vomit, it comes out of the mouth safely and doesn’t go back into the throat or lungs (which could cause choking or aspiration)
2% of which numbing agent will be used for arterial line placement?
Lidocaine
ETCO2 stands for......
End Tidal Carbon Dioxide
Subjects with an average daily consumption of a large quantity of coffee, tea, (_____ cups per day), energy drinks, or equivalent will be excluded.
> 6 cups
ENA-001 is a therapeutic agent which stimulates ________ for treatment of patients with mild to moderate respiratory and central nervous system (CNS) depression due to opioid (prescribed or illicit) overdose/multidrug (polysubstance) overdose in a hospital or an outof-hospital (community) setting.
Ventilation
If the DOSING subject has a BP of 70/110... Is this considered normal or should we inform the PI and why?
Inform the PI, systolic out of range.
Ranges for dosing:
Systolic <80 or > 160 mm Hg o Diastolic <40 or >105 mm Hg
Which antiemetic medication may be used for treatment of nausea and vomiting?
Ondansetron
What is the definition of hypocarbia or hypocapnia?
state of low carbon dioxide levels in the blood.
Subject reports history of alcohol and states
he drinks 4 glasses of wine everyday... is this exclusionary and why?
Yes exclusionary
(more than an average of two (2) drinks per day) within the past two (2) years.
Subjects need to be fasted for how long before dosing?
8 hours
The frequency of breathing shown on the ______monitor (f) should equal to what was shown on the pulse oximeter monitor for respiratory rate (RR) prior to applying the face mask.
PFT
Which medication can be used for treatment of pain on the injection site?
Acetaminophen
What is the definition of dyspnea?
shortness of breath.
often described as chest tightness, air hunger, or suffocation, commonly resulting from heart or lung conditions like asthma, COPD, or infections.
From 14 days prior to Screening until last visit, subjects must not take any medication or nutritional supplement other than the study drug(s) that will be administered during the study with the exception of _________ is allowed.
Hormonal contraceptives.
Combination Pills (COCs): Contain estrogen and progestin.
Progestin-Only Pills (Minipills): Contain only progestin; must be taken at the same time daily. Suitable for those who cannot take estrogen.
Bathroom breaks will be restricted during peak drug effect periods for how long after drug administration)
90 mins (1 hr 30 mins)
What app are we using on the computer to COLLECT the PFT values?
WFA
What app do you use to CALIBRATE the PFT machine.
Breeze
Define Allen's test.
The Allen's test is a bedside physical examination used to assess the arterial blood supply (patency) of the hand, ensuring there is adequate collateral circulation from the ulnar artery before puncturing the radial artery (e.g., for blood gas analysis). It evaluates if blood flow can be maintained by one artery if the other is damaged.
Subjects can test positive for THC during screening due to medical reasons because it is legal. Which inclusion criteria is this?
It is not an inclusion criteria, it is exclusionary. Subjects cannot be positive for THC at any point in the study.
ENA-001 will be delivered for IM at doses of
A. 0.43mg/kg, 1.29mg/kg, 1.71 mg/kg
B. 0.46mg/kg, 1.28mg/kg, 1.82 mg/kg
C. 0.47mg/kg, 1.29mg/kg, 1.76 mg/kg
D. 0.40mg/kg, 1.50mg/kg, 200 mg/kg
A. 0.43mg/kg, 1.29mg/kg, 1.71 mg/kg
What is the correct order of assessments during dosing?
Blood pressure, ABG, Vitals, Pk, spirometry (PFT)
Vitals, ABG, spirometry, blood pressure, PK
The spirometer for PFT will be calibrated using ___________ each morning of data acquisition.
3-liter calibration syringe
While using the indwelling arterial cannula line, a transducer is defined as?
a device connected to that line that measure systolic and diastolic blood pressure of the radial artery.