This is a single center study to evaluate the pharmacokinetics of ARMS-I a formulation that incorporates cetylpyridinium chloride (CPC), administered once as a single dose of three sprays orally, followed by multiple dosing (3x daily oral sprays) over days 3-6 and then a repeat pharmacokinetic study during the final oral dose administered as the first dose on day 7 to ascertain CPC accumulation.
ARMS Pharmaceuticals LLC intends to apply for approval of ARMS-I as a prescription drug for the prevention of influenza, rhinovirus and RSV (collectively, "vURTI's). The company plans on confirming the limited systemic bioavailability, through conducting a study to characterize the pharmacokinetics of ARMS-I administered orally in healthy adults. The primary objective of the study is to determine the pharmacokinetics of ARMS-I following oral administration to healthy subjects. Specifically, investigators will assess whether there is measurable systemic exposure and if so, to determine the plasma and pharyngeal fluid pharmacokinetic characteristics of ARMS-I after single and multiple oral dosing. The secondary objective will be to evaluate the safety and tolerability of ARMS-I.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
ProMedica Health System
Toledo, Ohio, United States
Plasma and pharyngeal fluid concentrations
Plasma and pharyngeal fluid concentrations of the active ingredient of ARMS-I (CPC) will be measured before and at multiple time points after the oral administration. If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include Cmax
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include AUC0-t
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include AUC0-24
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include C24
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include C48
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include Cl/F
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include Tmax
Time frame: 1 week
Plasma and pharyngeal fluid concentrations
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include t½
Time frame: 1 week
Frequency of adverse events
The frequency of adverse events (both solicited and unsolicited) will be assessed on a continuous basis throughout the study via safety assessments, observation direct participant reporting, and specific adverse reaction inquiry. Physical examinations, vital signs, ECG's, hematology, serum chemistries, coagulation studies and urinalysis will also be used to assess safety and tolerability
Time frame: 30 days from point of enrollment