PediatricPhase 1NCT05584683
A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection
A Phase 1 study testing Amoxicillin potassium clavulanate and Amoxicillin potassium clavulanate (Augmentin ES-600) in people with Pediatric and Bacterial Infections, run by Kaizen Bioscience Co. at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Pediatric, Bacterial Infections
- What is being tested?
- Amoxicillin potassium clavulanate and Amoxicillin potassium clavulanate (Augmentin ES-600)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 16 Dec 2024
- 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 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Patients will be excluded from the study if they satisfy any of the following criteria:
- Definite or suspected personal history or family history of significant hypersensitivity, intolerance, or allergy to penicillin, amoxicillin, amoxicillin clavulanate, or aspartame. History of reaction to multiple allergens (if considered clinically relevant by the principal investigator or designee).
- Children who weigh less than 5 kg or more than 40kg. Patients who are younger than 3 months or older than 24 months (i.e. past their 2nd birthday).
- Patients with a serious underlying disease, including failure to thrive, which could affect the safety, efficacy, or pharmacokinetics of the study medication.
- History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of study medication.
- History of diarrhea due to Clostridium difficile following treatment with antibiotics.
Show all 12Show fewer
- Have a serious underlying systemic clinical manifestation that may obscure response to infection (eg, cystic fibrosis, neoplasms, or juvenile diabetes), as determined by the investigator (or designee).
- 7. Have renal or hepatic dysfunction or insufficiency. 8. Have immune dysfunction or are receiving immunosuppressive therapy. 9. Have a chronic gastrointestinal condition (eg, malabsorption or inflammatory bowel disease), as determined by the investigator (or designee).
- 10. Have phenylketonuria or history of amoxicillin clavulanate associated cholestatic jaundice.
- 11. Have a systolic blood pressure <60 mmHg or capillary refill >3 seconds. 12. Use of any amoxicillin product within the previous 96 hours. 13. Poor peripheral venous access. 14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days, current enrollment in another clinical study that could impact the results of this study, or previous enrollment in this clinical study.
- 15. Patients who, in the opinion of the investigator (or designee), should not participate in this study.
- 16. Patients related to the sponsor or investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally
The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection.
Read the detailed description
This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric patients will each receive a single dose of LP-001 in a fed state while 15 pediatric patients will each receive a single dose of Augmentin ES-600 in a fed state. 3-4 blood draws per patient will be attempted up to 8 hours post dose.
- Conditions
- Pediatric, Bacterial Infections
- Being tested
- Amoxicillin potassium clavulanate, Amoxicillin potassium clavulanate (Augmentin ES-600)
- Keywords
- Amoxicillin, amoxicillin-clavulanate, Clavulanic acid, Bacterial Infections, Anti-Infective Agents
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin potassium clavulanateDrug
LP-001 will be reconstituted and administered as a single dose
Amoxicillin potassium clavulanate (Augmentin ES-600)Drug
Augmentin ES-600 will be reconstituted and administered as a single dose
| Study group | Role | What they receive |
|---|---|---|
| LP-001 Arm | Experimental | a novel amoxicillin/clavulanate formulation Receives: Drug: Amoxicillin potassium clavulanate |
| Augmentin ES-600 | Active comparator | Augmentin ES-600 Receives: Drug: Amoxicillin potassium clavulanate (Augmentin ES-600) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean plasma concentration-time curves of amoxicillin and clavulanic acid
Calculation of mean plasma
Measured: 6-8 hours post dose
Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
Calculation of AUC
Measured: 6-8 hours post dose
Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
Calculation of CMAX
Measured: 6-8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start9 Aug 2023
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- single site, single dose, open label, pharmacokinetic study
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaizen Bioscience Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584683
- Sponsor's protocol ID
- LP-001
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally
- ClinicalTrials.gov ID
- NCT05584683
- Acronym / sponsor ID
- LP-001
- Conditions
- Pediatric, Bacterial Infections
- Keywords
- Amoxicillin, amoxicillin-clavulanate, Clavulanic acid, Bacterial Infections, Anti-Infective Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kaizen Bioscience Co.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 18 Oct 2022 (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.
The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection.
Detailed description
This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric patients will each receive a single dose of LP-001 in a fed state while 15 pediatric patients will each receive a single dose of Augmentin ES-600 in a fed state. 3-4 blood draws per patient will be attempted up to 8 hours post dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single site, single dose, open label, pharmacokinetic study
| Arm | Type | Receives |
|---|---|---|
| LP-001 Arm | Experimental | Drug: Amoxicillin potassium clavulanatea novel amoxicillin/clavulanate formulation |
| Augmentin ES-600 | Active comparator | Drug: Amoxicillin potassium clavulanate (Augmentin ES-600)Augmentin ES-600 |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Definite or suspected personal history or family history of significant hypersensitivity, intolerance, or allergy to penicillin, amoxicillin, amoxicillin clavulanate, or aspartame. History of reaction to multiple allergens (if considered clinically relevant by the principal investigator or designee).
- Children who weigh less than 5 kg or more than 40kg. Patients who are younger than 3 months or older than 24 months (i.e. past their 2nd birthday).
- Patients with a serious underlying disease, including failure to thrive, which could affect the safety, efficacy, or pharmacokinetics of the study medication.
- History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of study medication.
- History of diarrhea due to Clostridium difficile following treatment with antibiotics.
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 |
|---|---|---|
| Amoxicillin potassium clavulanateLP-001 will be reconstituted and administered as a single dose | Drug | LP-001 Arm |
| Amoxicillin potassium clavulanate (Augmentin ES-600)Augmentin ES-600 will be reconstituted and administered as a single dose | Drug | Augmentin ES-600 |
Primary outcome
Mean plasma concentration-time curves of amoxicillin and clavulanic acid
Time frame: 6-8 hours post dose
Calculation of mean plasma
Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
Time frame: 6-8 hours post dose
Calculation of AUC
Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
Time frame: 6-8 hours post dose
Calculation of CMAX
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 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amoxicillin potassium clavulanate and Amoxicillin potassium clavulanate (Augmentin ES-600) in people with Pediatric and Bacterial Infections, run by Kaizen Bioscience Co. 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 0 inclusion and 12 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 5 Feb 2025. 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?
Mean plasma concentration-time curves of amoxicillin and clavulanic acid (time frame: 6-8 hours post dose). The study lists 3 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 5 Feb 2025.