Clinical Trials Logo
  1. Home
  2. Infections, Bacterial
  3. NCT02729038

Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function

Infections, Bacterial Clinical Trial

Official 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

Clinical Trial Summary

This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required. The objective of this study is to compare the pharmacokinetics of gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose in normal healthy subjects compared with subjects with mild, moderate, and severe renal impairment, and with subjects with end stage renal disease (ESRD). This is a Phase I, nonrandomized, open-label, parallel-group, multi-center, multi-part study. In Part 1, up to 16 subjects with normal renal function will be matched to approximately 8 subjects with moderate renal impairment, and approximately 8 subjects with severe renal impairment and/or subjects with ESRD not on hemodialysis for a total of approximately 32 subjects. In Part 2 (optional), approximately 4 to 8 subjects with normal renal function (if enrolled), approximately 4 to 8 subjects with mild renal impairment, and approximately 4 to 8 subjects with ESRD on hemodialysis will be enrolled for a total of approximately 12 to 24 subjects. The duration from Screening to the Follow-up Visit will be approximately 44 days for Part 1 and approximately 50 days for Part 2.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02729038
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date June 29, 2016
Completion date June 20, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT04079790 - Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects Phase 1
Completed NCT01934205 - To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944 Phase 1
Not yet recruiting NCT02177721 - Clinical Benefit, Safety and PK of Raxibacumab in Subjects Exposed to Bacillus Anthracis Phase 4
Suspended NCT01132417 - In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance N/A
Completed NCT00539994 - Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus Phase 2
Completed NCT01610388 - A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects Phase 1
Completed NCT01262885 - A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects Phase 1
Completed NCT00427141 - A Three-Part Study Of GSK580416 In Healthy Subjects Phase 1
Completed NCT04620486 - Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial N/A
Completed NCT02292498 - Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections N/A
Completed NCT01587768 - WEUKBRE5555: IMI PROTECT(Work Package 2): Liver Injury & Antibiotics N/A
Withdrawn NCT01039610 - A Single Center Four Part Study in Healthy Adult Subjects to Evaluate: the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose and Repeat Escalating Oral Doses of GSK945237; the Effect of Linezolid on Hematology Safety Parameters; and the Effects of GSK945237 and Moxifloxacin on QTc. Phase 1
Completed NCT00259909 - Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT00828867 - Single Dose Escalation First Time in Human PK Study Phase 1
Completed NCT01431989 - Amoxicillin Bioequivalence Study Brazil - Fast Phase 1
Completed NCT02778672 - Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia N/A
Completed NCT00896558 - A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects Phase 1
Completed NCT02045797 - Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections Phase 2
Active, not recruiting NCT05752019 - TAAI Erasmus Research Initiative to Fight CF: Monitoring Inflammation in CF Lung Disease Into a New Era
Completed NCT01648179 - A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects Phase 1