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A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects

NCT01648179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-22

No results posted yet for this study

Summary

This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.

Conditions

  • Infections, Bacterial

Interventions

DRUG

GSK1322322 (mesylate salt) Powder for Injection

1500 mg (mesylate salt) as free base, dissolved in sterile water for injection to a concentration of 100 mg/mL free base equivalent and sterilized via filtration. 15 mL of solution, equivalent to 1500 mg GSK 1322322, is the diluted into 0.9% Sodium Chloride Injection prior to infusion

DRUG

GSK1322322 (freebase) tablets

500 mg tablets for a 1500 mg total single dose (3 tablets). Taken with 240 mL of water

DRUG

GSK1322322 (mesylate salt) Powder for Oral Solution

1500 mg as a free base, dissolved in purified water to a concentration of 100 mg/mL free base equivalent. 15 mL of solution, equivalent to1500 mg GSK1322322 is administered orally with 225 mL of water

DRUG

GSK1322322 (freebase) tablets FED

Drug 500 mg tablets for a 1500 mg total single dose (3 tablets) (FED moderate fat meal) Taken with 240 mL of water

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01648179 on ClinicalTrials.gov