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

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients with a bacterial infection.

Detailed Description
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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 subjects will each receive a single dose of LP-001 in a fed state. 3 attempted blood draws per patient will be attempted up to 3 hours post dose.

Official Title
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An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics of LP-001 Oral Suspension in Children With a Bacterial Infection

Conditions
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Pediatric, Bacterial Infections

Intervention / Treatment
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* Drug: amoxicillin-clavulanic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female children between 3 months and 24 months of age. Written informed consent by the patient's parent or legal guardian and where appropriate. Patients recruited from inpatient/urgent care/emergency room with a bacterial infection. Examples of, but not limited to, bacterial infections could include: acute otitis media, community acquired pneumonia, aspiration (pneumonia), urinary tract infections, lymphadenitis, retropharyngeal abscess, peritonsillar abscess, animal or human bite, cellulitis, skin abscess or dental infection. 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. 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). Have wheezing exacerbation that may require treatment with corticosteroids, as determined by the investigator (or designee). Have renal or hepatic dysfunction or insufficiency. Have immune dysfunction or are receiving immunosuppressive therapy. Have a chronic gastrointestinal condition (eg, malabsorption or inflammatory bowel disease), as determined by the investigator (or designee). Have phenylketonuria or history of amoxicillin clavulanate associated cholestatic jaundice. Have a systolic blood pressure <60 mmHg or capillary refill >3 seconds. Use of any systemic corticosteroids or any amoxicillin product within the previous 96 hours. Poor peripheral venous access. 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, or previous enrollment in this clinical study. Patients who, in the opinion of the investigator (or designee), should not participate in this study. Patients related to the sponsor or investigator.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single site, single dose, open label, pharmacokinetic study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric patients with a bacterial infection<br> | Drug: amoxicillin-clavulanic acid<br>* Reconstituted amoxicillin/clavulanate oral suspension, LP-001, a new fixed dose combination will be administered in a single dose<br>* Other names: Amoxicillin/Clavulanate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean plasma concentration-time curves of amoxicillin and clavulanic acid |  | Up to 3 hours post dose | 
| Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination |  | Up to 3 hours post dose | 
| Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination |  | Up to 3 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amoxicillin, amoxicillin-clavulanate, Clavulanic acid, Bacterial Infections, Anti-Infective Agents