Delving into the Latest Updates on GSK-580416 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

580416, GSK 580416, GSK580416

Target

Top II

Action

inhibitors

Mechanism

Ribosomal proteins inhibitors, Top II inhibitors(Topoisomerase II inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Bacterial InfectionsRespiratory Tract Infections

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

License Organization-

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

Login to view timeline

A Three Part Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeat Escalating Oral Doses of GSK580416; the Safety, Tolerability, and Pharmacokinetics of GSK580416 Following a Loading Dose Regimen; and the Effect of Ketoconazole on the Pharmacokinetics of GSK580416

This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with ketoconazole, a PGP/CYP3A4 inhibitor.

Start Date01 Jun 2007

Sponsor / Collaborator

GSK Plc

NCT00427141

/ CompletedPhase 1

A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.

Start Date01 Oct 2006

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with GSK-580416

Login to view more data

100 Translational Medicine associated with GSK-580416

Login to view more data

100 Patents (Medical) associated with GSK-580416

Login to view more data

100 Deals associated with GSK-580416

Login to view more data