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Viral Upper Respiratory Tract InfectionPhase 2ARMS-INCT03026205

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

A Phase 2 study testing ARMS-I in people with Viral Upper Respiratory Tract Infection, run by University of Toledo Health Science Campus at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Viral Upper Respiratory Tract Infection
What is being tested?
ARMS-I
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2017to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ProMedica Health System

    Toledo, Ohio, 43606

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ARMS-I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARMS-IDrug

    Also called Cetylpyridinium Chloride

Study groups in NCT03026205
Study groupRoleWhat they receive
Single ArmExperimentalARMS-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.
Receives: Drug: ARMS-I

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 week

  2. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

  3. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

  4. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

  5. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

  6. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

  7. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

  8. Plasma and pharyngeal fluid concentrations

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

    Measured: 1 week

Secondary outcomes (1)

  1. 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

    Measured: 30 days from point of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026205
Sponsor's protocol ID
16-191
Acronym
ARMS-I
Status last verified
Apr 2019
First submitted
12 Jan 2017
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARMS-I in people with Viral Upper Respiratory Tract Infection, run by University of Toledo Health Science Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma and pharyngeal fluid concentrations (time frame: 1 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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