NCT01495065

A Study to Evaluate Single and Repeat Doses of IV GSK2251052 in Healthy Male Japanese and Caucasian Subjects and Repeat Doses of Supratherapeutic Doses of IV GSK2251052 in Healthy Volunteers

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Community-acquired Infection

Interventions

Type	Name	Description
DRUG	GSK2251052 750 mg	Treatment A: 750 mg IV GSK2251052 single dose
DRUG	GSK2251052 1500 mg	Treatment B: 1500 mg IV GSK2251052 single dose
DRUG	GSK2251052 1500 mg BID	Treatment C: 1500 mg IV GSK2251052 BID or placebo for 12 days
DRUG	GSK2251052 2250 mg	Treatment D: On Day 1 a single dose of GSK2251052 2250 mg IV administered over 60 minutes; Days 4 - 12 BID doses of GSK2251052 2250 mg IV (for 9 days), fasted
DRUG	GSK2251052 3000 mg	Treatment E: On Day 1 a single dose of GSK2251052 3000 mg IV administered over 60 minutes; Days 4 - 12 BID doses of GSK2251052 3000mg IV (for 9 days), fasted
DRUG	GSK2251052 0.9% saline	Treatment P: On Day 1 a single dose of 0.9% saline IV administered over 60 minutes; On Days 4 - 12 BID doses of 0.9% saline (for 9 days), fasted

Timeline

• Start date: 2011-12-19
• Primary completion: 2012-02-17
• Completion: 2012-02-17
• First posted: 2011-12-19
• Last updated: 2017-06-15

Locations

1 site across 1 country: United States