Clinical Trials Logo
  1. Home
  2. Infections, Bacterial
  3. NCT01934205

To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944

Infections, Bacterial Clinical Trial

Official title:
An Open-label Study To Evaluate Plasma and Pulmonary Pharmacokinetics Following Intravenous Administration of GSK2140944 in Healthy Adult Subjects (BTZ116666)

Clinical Trial Summary

Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and alveolar macrophages represent an ideal estimate of concentrations at the site of infection and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial concentrations via BAL is not routine in clinical practice due to its complex methodology and poor patient tolerability. This study will evaluate intrapulmonary and plasma pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are necessary to adequately model the pulmonary pharmacokinetic profile.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01934205
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date September 25, 2013
Completion date December 21, 2013
View Details
See also
  Status Clinical Trial Phase
Completed NCT04079790 - Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects 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
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Not yet recruiting NCT06440304 - Therapeutic Options for CRAB Phase 4
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