Overview

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

Status:
Withdrawn
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Toledo Health Science Campus
Collaborators:
ARMS Pharmaceutical LLC
Pediatric Pharmacology Research Center
ProMedica Health System
The University of Toledo
Treatments:
Cetylpyridinium
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- Pregnancy or breastfeeding

- Known allergic reactions to study drug components, including ingredients present in
the formulation.

- Treatment with another investigational drug within 30 days of dosing

- Lack of ability to fully understand the informed consent form. This will be determined
by the recruiter/interviewer after explaining the consent and observing the subject
reading the consent.

- Ingestion of prescription medications, grapefruit juice, or St John's Wort starting 14
days or 5 half-lives before dosing, whichever is longer. Women may use oral
contraceptives.

- Ingestion of herbal supplements or over-the-counter medications starting 7 days before
dosing

- Use of any form of tobacco, including cigarette smoking, pipe smoking, or oral
tobacco; if a former smoker or tobacco user, the subject must not have used tobacco
for 90 days before screening

- Any specific condition that, in the judgment of the Principal Investigator, precludes
participation because it could affect subject safety

- History of current use of narcotics, or recreational drug use.

- Use of > 7 alcoholic beverages within 1 week

- Use of any other intra-oral product (especially antiseptic) except for dental hygiene

- Use of any systemic antimicrobial agent within 30 days of screening

- Prior or current history of seasonal allergies, chronic sinusitis or rhinitis

- Presence of oral lesions

- Use of dentures

- Dental treatment currently in progress (implants, root canals, complex restorative
procedures)