Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101

A Randomized, Crossover, Controlled, Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101 in Healthy Adult Subjects

Pharmacokinetic (PK) study of L-arginine after exaggerated oral use of the novel dentifrice product COL101 after repeated daily applications in healthy adult subjects.

Study Overview

• Status: Completed
• Conditions: Caries,Dental
• Intervention / Treatment: Drug: L Arginine; Drug: Sodium Fluoride

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female 18 - 65 years of age;
• In good health as determined by medical history, physical and dental examination, vital signs and clinical laboratory safety assessment;
• Agree to delay any elective dentistry including dental prophylaxis until the study has been completed;
• Agree to refrain from supplements containing arginine throughout the duration of the study;
• In the case of females of childbearing potential (unless surgically sterilized [hysterectomy, bilateral oophorectomy, tubal ligation] or are postmenopausal for at least 12 months), are using one acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, partner's vasectomy). Abstinence or vasectomies are acceptable if the female subject agrees to implement an acceptable form of birth control if her lifestyle/partner changes;
• For females of childbearing potential, have a negative serum pregnancy test (SPT) at the Screening visit and a negative urine pregnancy test (UPT) on Day -2 prior to randomization, and agree to submit to a SPT at the end of study (EOS) visit;
• Are free of any systemic or dermatologic disorder, which, in the opinion of the Principal Investigator (PI), will interfere with the study results or increase the risk of adverse events (AEs); and
• Read, understand, and provide signed informed consent.

Exclusion Criteria:

• A female who is pregnant, plans to become pregnant during the study, or is breastfeeding a child;
• Are actively being treated for periodontitis, gingivitis or caries;
• Have severe periodontal disease, as characterized by purulent exudates, generalized mobility, or severe recession;
• Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal (GI), endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions, that might interfere with the study results in the investigator's opinion;
• Any condition which, in the investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study;
• Have known or suspected allergies to oral care products, toothpaste, or ingredients in toothpaste;
• Immunization within 10 days of Day 1;
• Anticipated need for surgery or hospitalization during the study;
• Consumed alcohol within 48 hours prior to Day 1 or refuses to abstain from alcohol throughout the duration of the study;
• History of heavy smoking (i.e., more than 10 cigarettes a day or the tobacco/nicotine equivalent) within 3 months of screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study;
• Consumed caffeine (i.e., coffee, tea, caffeinated soda, chocolate) within 48 hours prior to Day 1 or refuses to abstain from caffeine throughout the duration of the study;
• Donation or loss of blood (excluding volume drawn at screening) of ≥ 450 mL within 3 months of Day 1;
• Active or lifetime infection (e.g., negative test for human immunodeficiency virus (HIV) and hepatitis, and no history of tuberculosis and syphilis) or a history of severe infection during the 30 days prior to screening;
• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment;
• Is unwilling or unable to refrain from using prescription medications for 30 days prior to Day 1 or over the counter medications, herbal preparations, and supplements for 14 days prior to Day 1 (excluding permitted forms of contraception and occasional use of acetaminophen [up to 2 g in 24 hours]);
• Inability or unlikeliness of the subject to comply with the dose schedule and study evaluations, in the opinion of the investigator;
• Is currently participating in any clinical trial;
• Has received any investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to study Day 1;
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data;
• Inability of the subject (or legally authorized representative) to comprehend the electronic informed consent form (eICF) or unwillingness to sign the eICF; and/or
• Subject meets eligibility criteria, but study is filled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; toothpaste containing 8% L-arginine	Drug: L Arginine; toothpaste; Drug: Sodium Fluoride; toothpaste
Active Comparator: Group II; toothpaste containing 0.24% sodium fluoride	Drug: L Arginine; toothpaste; Drug: Sodium Fluoride; toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arginine in blood	Measurement of arginine in blood after oral brushing	Day 1 for 24 hours
Arginine in blood	Measurement of arginine in blood after oral brushing	Day 7 for 24 hours
Arginine in blood	Measurement of arginine in blood after oral brushing	Day 10 for 24 hours
Arginine in blood	Measurement of arginine in blood after oral brushing	Day 16 for 24 hours

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Irina Krause, RN, MSN, TKL

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: arginine
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: CRO-2023-10-TKL-GPS-JM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No