Community-acquired Infection Clinical Trial
Official title:
A Two Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK2251052 After Single Ascending Dosesand Repeat Doses of IV GSK2251052 in Healthy Male Japanese and Caucasian Subjects and a Repeat Dose Study to Evaluatesupratherapeutic Doses of IV GSK2251052 in Healthy Volunteers
This is a two-part study. Part A is a three-period study in approximately 24 healthy male
Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to
investigate the safety, tolerability, and pharmacokinetics of single ascending intravenous
doses of GSK2251052. Period 3 is a single blind, placebo controlled, repeat fixed dose
design to evaluate the safety, tolerability and pharmacokinetics of multiple intravenous
doses of GSK2251052 for 12 days. The selection of the repeat IV dose will be based on the
results from Periods 1 and 2. Japanese subjects will be stratified based on their metabolic
genotype, polymorphic or wild-type for ADH and ALDH. Caucasian subjects are not anticipated
to have these enzyme polymorphisms and therefore will not be stratified.
Part B is a two cohort, single-blind, randomized, placebo-controlled, dose-rising, repeat
dose study in approximately 24 healthy male and female subjects to evaluate the safety,
tolerability, and pharmacokinetics of supratherapeutic IV doses of GSK2251052 for 10 days.
Cohort 1 subjects will be randomized to receive 2250 mg of GSK2251052 or placebo and Cohort
2 subjects will be randomized to receive 3000 mg GSK2251052 or placebo. The decision to
conduct Cohort 2 of Part B will be based on the available toxicology cover results from
ongoing preclinical toxicity studies.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01702350 -
A Four Part Study to Investigate Relative Bioavailability, Safety and Tolerability of up to 5 Oral Formulation of GSK2251052 in Order to Identify a Formulation for Further Evaluation in a Future Later Phase Study
|
Phase 1 | |
| Completed |
NCT00233376 -
Computerized Decision Support System for Antibiotic Treatment
|
Phase 3 | |
| Completed |
NCT01267968 -
An Open-label, Randomized, Single Period, Parallel-Cohort Study To Evaluate Serum and Pulmonary Pharmacokinetics Following Single and Multiple Dose Administration of Intravenous GSK2251052 in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT01475695 -
GSK2251052 Mass Balance in Healthy Adult Subjects
|
Phase 1 |