GSK-BTZ116849

Study Sponsor: GSK

Study Title

A Phase I, Open-Label, Single-Dose, Multi-Part Study to Assess the Pharmacokinetics of Gepotidacin (GSK2140944) in Male and Female Adult Subjects with Varying Degrees of Renal Impairment and in Matched Control Subjects with Normal Renal Function

Medicine or Vaccine (generic name)

gepotidacin

Sponsor Identification Number

BTZ116849

Trial Registry Identification Number(#'s)

NCT02729038

Medical Condition

Infections, Bacterial

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=116849

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT02729038

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

The data for this study is available in CDISC format.

Date Added to this Site

June 2020