ARMS-I (a Formulation of Cetylpyridinium Chloride -CPC)

NCT03026205 | Withdrawn Phase 2 DMC

• 1 other identifier: 16-191
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (8)

• 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

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include AUC0-t

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include AUC0-24

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include C24

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include C48

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include Cl/F

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include Tmax

  1 week

• Plasma and pharyngeal fluid concentrations

  If plasma concentrations are measureable (above the LLOQ) then the assessed PK parameters will include t½

  1 week

Secondary Outcomes (1)

• Frequency of adverse events

  30 days from point of enrollment

Study Arms (1)

Single Arm

EXPERIMENTAL

ARMS-I dosage of 0.75 mg will be sprayed orally in the mouth once as a single dose of four sprays on Day 1, and then three times a day starting on Day 3 for 4 Days.

Drug: ARMS-I

Interventions

ARMS-I DRUG

Also known as: Cetylpyridinium Chloride

Single Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18 to 45 years of age, inclusive
• Ability to understand the consent process and procedures
• Informed consent obtained and signed
• Comprehension of the protocol, which will be determined by the recruiter after explaining the procedures
• Subjects agree to be available for all study visits. Subjects will be asked if they have any travel plans, and whether staff could use alternate contact information that will be provided.
• General good health as determined by the Study Physician, without current medical illness or clinically significant abnormal physical examination findings that classify the subject as other than healthy
• Negative urine pregnancy test at screening and a negative urine pregnancy test on the day of initial pharmacokinetic sampling for all female subjects of child bearing potential
• Negative urine toxicity screen for marijuana, cocaine metabolites, amphetamines, opiates, PCP, barbiturates, benzodiazepines
• Negative breathalyzer for alcohol
• Body mass index (BMI) between 18 and 35 (inclusive) \[weight (kg)\]/ \[height (m)2\]
• No tobacco/nicotine use for at least 3 months prior to study enrollment
• No oral disease or lesions
• Agreement to refrain from eating or drinking except for water for 8 hours prior to drug administration and eating or drinking anything for 4 hours after dosing on the days of pharmacokinetic sampling
• Agreement by subjects with reproductive potential to use an adequate method of contraception during the study and for one week after study drug administration. Female subjects must agree to the use of TWO reliable methods of contraception while receiving study drug and for 4 weeks after study drug administration, which can include: condoms, spermicidal gel, diaphragm, hormonal or non-hormonal intrauterine device, surgical sterilization, oral contraceptive pill, depot progesterone injections, and sexual abstinence. If a male subject is sexually active, the subject and his partner must agree to use at least one of the above listed contraceptive methods.
• If the subject uses abstinence and becomes sexually active during the study, they must agree to use TWO forms of contraception if female and ONE if male, of the above listed contraceptive methods.

You may not qualify if:

• Hypertension with confirmed systolic blood pressure \>140 mmHg or confirmed diastolic blood pressure \>90 mmHg, measured after 10 - 15 minutes of rest
• Morbid obesity (BMI\>35)
• Current diagnosis of pulmonary disease including asthma or COPD, which has required use of asthma medications within the past year
• History of or current diagnosis of diabetes
• Autoimmune disorder, such as systemic lupus erythematosus, Wegener's disease, or rheumatoid arthritis, among other conditions
• History of malignancy except low-grade skin cancer, (i.e., basal cell carcinoma which has been surgically cured)
• Chronic renal, hepatic, or pulmonary disease condition that could interfere with the absorption of the study drug (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease)
• Blood donation within the previous 6 weeks
• History of cardiac rhythm abnormality
• History of prolonged QT interval
• Prolongation of QTcB interval (i.e., confirmed QTcB interval \>450 milliseconds)
• Clinically significant abnormal electrocardiogram at screening in the judgment of the investigator, or based on the formal ECG reading; history of any cardiac abnormalities, including conduction abnormalities such as Wolff-Parkinson-White Syndrome, dysrhythmias, or coronary artery disease
• Laboratory values outside the normal ranges in Appendix for the following tests: blood cell counts (white blood cell counts \[WBC\], hemoglobin, platelets), serum chemistry (sodium, potassium, calcium, chloride, CO2, creatinine, glucose, BUN, AST, AP, ALT, total bilirubin, protein, albumin, amylase), urinalysis for glucose, protein and blood (with proviso for re-testing menstruating females). If CK is above normal range at baseline, but not clinically significant, the subject can be included.
• Positive serology results for HIV, HBsAg, or HCV infections
• Febrile illness with temperature documented \>38°C within 7 days of dosing

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead
• ProMedica Health System: collaborator
• The University of Toledo: collaborator
• ARMS Pharmaceutical LLC: collaborator
• Pediatric Pharmacology Research Center: collaborator

Study Sites (1)

ProMedica Health System

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Interventions

Cetylpyridinium

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey L Blumer, PhD, MD

  Professor, University of Toledo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)