Infections, Bacterial Clinical Trial
Official title:
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.
GSK945237 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK945237 has demonstrated in vitro and in vivo activity against Gram positive [including methicillin resistant Staphylococcus aureus (MRSA)] and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials. This study will be conducted in four (4) parts, with a single oral dose being explored in Part A (2400 mg) and repeat oral doses (b.i.d. and q.d.) being explored in Part B. Parts C and D will be optional evaluations of repeat oral doses of linezolid and a comparative evaluation of the effect of GSK945237 and moxifloxacin, respectively. Parts A and B will be single-blind, randomized, placebo-controlled, dose-rising (Part B only) studies of healthy subjects to evaluate the safety, tolerability and pharmacokinetics of GSK945237. The proposed doses range from 400 mg to 2400 mg. Part C will be a single-blind, randomized, and placebo-controlled repeat dose evaluation of 600 mg (b.i.d.) of linezolid. Part D will be a single-blind, randomized, placebo-controlled, two period crossover study. The proposed doses for Part D will be 1200 mg GSK945237 and 400 mg moxifloxacin.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| 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 | |
| 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 | |
| Completed |
NCT02729038 -
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
|
Phase 1 |