Infections, Bacterial Clinical Trial
Official title:
A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety,
tolerability, and relative bioavailability of the 2 free base tablet formulations (roller
compacted [RC] and high shear wet granulation [HSWG]) compared to the reference capsule
formulation under fasted conditions. This is a 3-period; cross-over study that will guide
which gepotidacin formulation will be used for future studies. Following review of
pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed
with Parts 1b and 2.
Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the
selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected
gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will
be evaluated under fasted conditions.
The duration of the study (from Screening to the Follow-up visit) will be approximately 44
days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The
approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3
treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12
Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.
n/a
| 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 |