NCT00828867

Single Dose Escalation First Time in Human PK Study

A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Investigational Study Drug in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-11-14
• Primary completion: 2009-12-07
• Completion: 2009-12-07
• First posted: 2009-01-26
• Last updated: 2017-06-20

Locations

1 site across 1 country: Australia