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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

NCT01495065 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-06-15

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-19
Primary Completion
2012-02-17
Completion
2012-02-17

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495065 on ClinicalTrials.gov