Phase 1, Open-Label, single arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants from 2 to less than 12 years of age with a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis with Antibiotics

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522916-17-00

Enrollment

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Brief summary

•AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin., •Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin., •Maximum observed plasma concentration (Cmax) of gepotidacin., •Apparent oral clearance (CL/F) of gepotidacin., •Apparent volume of distribution (Vz/F) of gepotidacin., •Terminal phase half-life (t1/2) of gepotidacin.

Detailed description

•Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs);, •Change from baseline in vital signs: Temperature;, •Change from baseline in vital signs: Blood Pressure;, •Change from baseline in vital signs: Pulse Rate;, •Change from baseline in Electrocardiogram (ECG).

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
•AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin., •Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin., •Maximum observed plasma concentration (Cmax) of gepotidacin., •Apparent oral clearance (CL/F) of gepotidacin., •Apparent volume of distribution (Vz/F) of gepotidacin., •Terminal phase half-life (t1/2) of gepotidacin.	—

Measure

Time frame

—

Secondary

Measure	Time frame
•Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs);, •Change from baseline in vital signs: Temperature;, •Change from baseline in vital signs: Blood Pressure;, •Change from baseline in vital signs: Pulse Rate;, •Change from baseline in Electrocardiogram (ECG).	—

Outcome results