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

NCT06182267 | Completed Phase 1 FDA Drug

• 1 other identifier: CRO-2023-10-TKL-GPS-JM
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caries,Dental

Keywords

arginine

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

toothpaste containing 8% L-arginine

Drug: L Arginine; Drug: Sodium Fluoride

Group II

ACTIVE COMPARATOR

toothpaste containing 0.24% sodium fluoride

Drug: L Arginine; Drug: Sodium Fluoride

Interventions

L Arginine DRUG

toothpaste

Group I; Group II

Sodium Fluoride DRUG

toothpaste

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[up to 2 g in 24 hours\]);

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

TKL Research, Inc

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Arginine; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Irina Krause, RN, MSN

  TKL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: November 27, 2023
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)