CompletedPhase 1

A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection

United States39 participantsStarted 2023-08-09

Plain-language 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.

Who can participate

Age range

3 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. decreased or absent mobility of the tympanic membrane
. yellow or white discoloration of the tympanic membrane
. opacification of the tympanic membrane. iii) acute inflammation demonstrated by:

Exclusion 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean plasma concentration-time curves of amoxicillin and clavulanic acid

Timeframe: 6-8 hours post dose

Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination

Timeframe: 6-8 hours post dose

Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination

Timeframe: 6-8 hours post dose

Trial details

NCT IDNCT05584683

SponsorKaizen Bioscience Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-16

View on ClinicalTrials.gov More Pediatric trials

Who can participate

Age range

3 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. decreased or absent mobility of the tympanic membrane
. yellow or white discoloration of the tympanic membrane
. opacification of the tympanic membrane. iii) acute inflammation demonstrated by:

Exclusion 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.

What they're measuring

Mean plasma concentration-time curves of amoxicillin and clavulanic acid

Timeframe: 6-8 hours post dose

Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination

Timeframe: 6-8 hours post dose

Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination

Timeframe: 6-8 hours post dose