Completed PHASE1 INTERVENTIONAL 9-arm 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

Sponsor: GlaxoSmithKline

Conditions Infections, Bacterial

Interventions 100 mg GSK investigational drug 1500 mg GSK investigational drug 200 mg GSK investigational drug 2000 mg GSK investigational drug 3000mg GSK investigational drug 400 mg GSK investigational drug 4000mg GSK investigational drug 800 mg GSK investigational drug 800mg fed GSK investigational drug

Updated 6 times since 2017 Last updated: Jun 19, 2017 Started: Nov 14, 2008 Primary completion: Dec 7, 2009 Completion: Dec 7, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Infections, Bacterial and is currently completed. GlaxoSmithKline leads this study, which shows 6 recorded versions since 2008 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jul 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Jul 2017 [monthly]

Completed PHASE1

First recorded

Nov 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Randwick, Australia