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Single Dose Escalation First Time in Human PK Study

NCT00828867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-06-20

No results posted yet for this study

Summary

This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects

Conditions

  • Infections, Bacterial

Interventions

DRUG

100 mg GSK investigational drug

DRUG

200 mg GSK investigational drug

DRUG

400 mg GSK investigational drug

DRUG

800 mg GSK investigational drug

DRUG

2000 mg GSK investigational drug

DRUG

1500 mg GSK investigational drug

DRUG

800mg fed GSK investigational drug

DRUG

3000mg GSK investigational drug

DRUG

4000mg GSK investigational drug

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-11-14
Primary Completion
2009-12-07
Completion
2009-12-07

Countries

  • Australia

Study Locations

More Related Trials

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 NCT00828867 on ClinicalTrials.gov