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Intravenous Microdose Pharmacokinetic (PK) Study With [14C]-GSK2239633

2014-08-27 03:15:16 | BioPortfolio

Summary

This study is a first administration to man microdose study to describe the pharmacokinetics of GSK2239633.

Description

The different shapes of the pharmacokinetic (PK) profiles following administration of GSK2239633 in rat and dog make it difficult to reliably predict the human PK profile. This microdose study will provide an early readout on the distribution and clearance profile of the drug in man and will be used to model potential clinical oral doses. The study will be conducted using an open-label, single dose design in one group of healthy male volunteers. Each subject will receive a single intravenous infusion of 100ug GSK2239633 (containing approximately 10kBq of [14C]-GSK2239633), administered over 15 minutes. Subjects will attend for a screening visit within 30 days prior to Day 1 and receive a single dose infusion of study drug on Day 1. Blood and urine samples will be taken over 48 hours for pharmacokinetic and total radioactivity analysis, and safety and tolerability will be monitored. Subjects will be discharged on Day 3 and a follow-up telephone call will be made 4-10 days post-dose.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Asthma

Intervention

GSK2239633

Location

GSK Investigational Site
Zuidlaren
Netherlands
9471 GP

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:16-0400

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