Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT03026205
Status:
WITHDRAWN
Last Update Posted:
2019-04-17
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARMS-I (a Formulation of Cetylpyridinium Chloride -CPC)
Sponsor:
University of Toledo Health Science Campus
Organization:
Study Overview
Official Title:
Evaluation of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Orally Administered ARMS-I Administered in Healthy Adults, Aged 18-45 Years
Status:
WITHDRAWN
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARMS-I
Brief Summary:
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.
Detailed Description:
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: