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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers

NCT01640990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-06-12

No results posted yet for this study

Summary

This study is a single dose evaluation using an open label dose escalating design. Cohort1 will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg). Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2 hours after cessation of the intravenous infusion. PK measurements and measurement of erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30 minute intervals during the infusion of GW328267X up to and including 1 hour after cessation of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be done.

Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1. It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort 2 will consist of 3 healthy male volunteers and the study procedures for this additional Cohort will be the same as that described for Cohort 1.

Conditions

  • Lung Injury, Acute

Interventions

DRUG

Saline

30mins run-in period

DRUG

GW328267X (total dose of 12mcg)

8 mcg/h for 1.5 hours (total dose of 12mcg)

DRUG

GW328267X (total dose of 40mcg)

10 mcg/h for 4 hours (total dose of 40 mcg)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-22
Primary Completion
2011-12-09
Completion
2011-12-09

Countries

  • United Kingdom

Study Locations

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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 NCT01640990 on ClinicalTrials.gov