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 range3 Months – 24 Months

SexALL

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

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 range3 Months – 24 Months

SexALL

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