Caries,DentalPhase 1NCT06182267
Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101
A Phase 1 study testing L Arginine and Sodium Fluoride in people with Caries,Dental, run by Colgate Palmolive at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- L Arginine and Sodium Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 22 Dec 2023
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Caries,Dental
- Being tested
- L Arginine, Sodium Fluoride
- Keywords
- arginine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L ArginineDrug
toothpaste
Sodium FluorideDrug
toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | toothpaste containing 8% L-arginine Receives: Drug: L Arginine; Drug: Sodium Fluoride |
| Group II | Active comparator | toothpaste containing 0.24% sodium fluoride Receives: Drug: L Arginine; Drug: Sodium Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arginine in blood
Measurement of arginine in blood after oral brushing
Measured: Day 1 for 24 hours
Arginine in blood
Measurement of arginine in blood after oral brushing
Measured: Day 7 for 24 hours
Arginine in blood
Measurement of arginine in blood after oral brushing
Measured: Day 10 for 24 hours
Arginine in blood
Measurement of arginine in blood after oral brushing
Measured: Day 16 for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start27 Nov 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Krause, RN, MSN, Study director, TKL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182267
- Sponsor's protocol ID
- CRO-2023-10-TKL-GPS-JM
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Controlled, Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06182267
- Acronym / sponsor ID
- CRO-2023-10-TKL-GPS-JM
- Conditions
- Caries,Dental
- Keywords
- arginine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: L Arginine, Drug: Sodium Fluoridetoothpaste containing 8% L-arginine |
| Group II | Active comparator | Drug: L Arginine, Drug: Sodium Fluoridetoothpaste containing 0.24% sodium fluoride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L Argininetoothpaste | Drug | Group I, Group II |
| Sodium Fluoridetoothpaste | Drug | Group I, Group II |
Primary outcome
Arginine in blood
Time frame: Day 1 for 24 hours
Measurement of arginine in blood after oral brushing
Arginine in blood
Time frame: Day 7 for 24 hours
Measurement of arginine in blood after oral brushing
Arginine in blood
Time frame: Day 10 for 24 hours
Measurement of arginine in blood after oral brushing
Arginine in blood
Time frame: Day 16 for 24 hours
Measurement of arginine in blood after oral brushing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Krause, RN, MSN study director
TKL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L Arginine and Sodium Fluoride in people with Caries,Dental, run by Colgate Palmolive 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 8 inclusion and 21 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: finished, as of the sponsor's last update on 2 Jan 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Arginine in blood (time frame: Day 1 for 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.