Pharmacokinetic and Safety Study of Metronidazole Oral Suspension in Pediatric Patients With Anaerobic Bacterial Infection

NCT07146217 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ATI-1501-0X
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label, single-arm, pharmacokinetic and safety study of Likmez® in pediatric patients aged 12 months to \<4 years with anaerobic bacterial infection

Conditions

Bacterial Infections

Keywords

Anaerobic Bacterial Infection

Outcome Measures

Primary Outcomes (5)

• Maximum plasma concentration [Cmax]

  Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Cmax

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Time to reach at maximum plasma concentration [Tmax]

  Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Tmax

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Area under the concentration-time curve from time 0 to time 't' '[AUC0-t]

  Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by AUC0-t

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Volume of distribution [Vd/F]

  Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Vd/F

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Apparent clearance of drug from plasma [CLTotal/F]

  Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by CLTotal/F. The CLTotal will be calculated by dividing the dose by the AUC for the given dosing interval \[Dose/ AUC0-Tau\]

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

Secondary Outcomes (14)

• Comparison of AUC0-t in Pediatric Patients Without Prior IV Metronidazole to Adult Single-Dose PK Data

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Comparison of Cmax in Pediatric Patients Without Prior IV Metronidazole to Adult Single-Dose PK Data

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Comparison of AUC0-t in Pediatric Patients With Prior IV Metronidazole to Adult Steady-State PK Data

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Comparison of Cmax in Pediatric Patients With Prior IV Metronidazole to Adult Steady-State PK Data

  Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

• Number of Participants With Adverse Events as Assessed by CTCAE v5.0

  From screening to end of study, up to 26 days

Study Arms (1)

Likmez® (metronidazole) Oral Suspension

EXPERIMENTAL

Drug: Likmez® (metronidazole) Oral Suspension

Interventions

Likmez® (metronidazole) Oral Suspension DRUG

Each patient will receive 7.5 mg/kg of Likmez® every 6 hours, with a concentration of 100 mg metronidazole/mL

Likmez® (metronidazole) Oral Suspension

Eligibility Criteria

• Age: 12 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between ≥ 12 months and \< 4 years till the time of dosing in the study
• Sufficient venous access to permit cannulation for required blood sample collection.
• Ability to swallow oral liquids.
• Clinical diagnosis with suspected or culture-confirmed anaerobic bacterial infection with pathogens known to be sensitive to metronidazole and requiring treatment for any of the below mentioned infections:
• Septicaemia and Bacteraemia
• Intra-abdominal infections (including peritonitis, intra-abdominal abscess, and liver abscess)
• Bone and joint infections (including osteomyelitis)
• Lower respiratory tract infections (including pneumonia, empyema, and lung abscess)
• Patients with clinical diagnosis of polymicrobial infection who can be administered Likmez® with other antibacterial agents without clinically significant drug-drug interactions. Note: These patients will be allowed concomitant administration with other antibacterial drugs, not having an interaction with metronidazole (Refer APPENDIX B: List of Antibiotic Drugs Having Interaction with Metronidazole, for the list of antibiotic drugs having interaction with metronidazole). If co-administration of such medications cannot be avoided, PI should consider taking steps to minimize the risk of QT/QTc interval prolongation and torsade de pointes (TdP), such as electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
• Any of the above mentioned clinical conditions, which would allow them to initiate the treatment with IV or oral anti-bacterial drugs with activity against anaerobic bacteria (e.g., IV treatment such as a betalactam/beta-lactamase inhibitor or a cephalosporin plus metronidazole; or oral treatment such as amoxicillin, amoxicillin-clavulanate, or azithromycin) followed by treatment with i.e. Likmez® at 7.5 mg/kg, to complete the treatment course and are able to provide PK samples for the study.
• Parents/legal guardians of the patient have provided Written Informed Consent prior to initiation of any protocol-specific procedures.

You may not qualify if:

• History of anaphylactic reaction to metronidazole or other nitroimidazole derivatives (e.g., tinidazole).
• Presence of clinically significant encephalopathy or peripheral neuropathy.
• Presence or history of clinically significant convulsive seizure disorders.
• Presence or history of any hematologic condition or blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening).
• Abnormal laboratory results for the following analyses showing any of the following abnormal results:
• Aspartate aminotransferase (AST), alanine transaminase (ALT)\>2 X the upper limit of the reference range
• WBC count \<3.0 X 109 /L
• Total bilirubin ≥20 μmol/L (1.17 mg/dL); except in patients with isolated elevation of indirect bilirubin relating to Gilbert syndrome
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 using the Bedside Schwartz methods for estimation (eGFR = 41.3 x height/serum creatinine (Scr), where height is in meters and Scr in mg/dL)
• Hemoglobin \<8 g/dL
• Platelets \<100,000/μL
• History or presence of any clinically significant disease or disorder that, in the opinion of the investigator, would put the patient at risk or would potentially influence the results of the study (e.g. evidence of gastrointestinal, hepatic, or renal disease that could affect absorption, distribution, metabolism, or excretion of the orally administered study drug).
• Patients with a history of hereditary fructose intolerance (HFI) or rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
• Patients with a known sensitivity to glucose (e.g. patients with a diagnosis of diabetes or patients taking a ketogenic diet).
• Patients with a history of Severe cutaneous adverse reactions (SCARs), including Stevens Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).

Sponsors & Collaborators

• Saptalis Pharmaceuticals LLC: lead
• CBCC Global Research: collaborator

Study Sites (3)

Bioresearch Partner

Miami, Florida, 33155, United States

Location

Empire Medical Clinical Trials

Miami, Florida, 33183, United States

Location

Aavon Clinical Trials

Richmond, Texas, 77407, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Metronidazole; Suspensions

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Polireddy Dondeti, PhD

  President & CEO

  STUDY CHAIR

Central Study Contacts

Santhy John

CONTACT

631-231-2751; santhy.john@saptalis.com

Veera Somasani

CONTACT

631-231-2751; veera.somasani@saptalis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (3)