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Blood Levels and Effects of GSK1325756 in Healthy Adult Volunteers Aged 40 to 80 Years Old

NCT01267006 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-07-07

No results posted yet for this study

Summary

This study will invite two groups of volunteers to participate.

The data from one group of volunteers will be used to find out how much study drug, known as GSK1325756, is in the blood after taking the drug twice in one day. Data will also collected to find out if the level of cetain blood cells, known as neutrophils, change significantly after taking the study drug twice in one day. This group of volunteers will be aged 40 to 64 years of age.

The data from the other group of volunteers will be used to find out if taking the study drug, GSK1325756, twice in one day with or without food, makes a difference to the level of study drug in the blood. This group of volunteers will also provide data to find out if any study drug metabolites are present in the bile, a fluid secreted by the liver. This group of volunteers will be aged 65 to 80 years of age.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK1325756

GSK1325756 will be available as white, film coated immediate release tablets with dose strengths of 50 mg, 100 mg and 200 mg. The tablets will be administered twice daily by oral route with 240 milliliters of water.

DRUG

Placebo tablet

Placebo will be available as white film coated GSK1325756 matching tablet which will be administered twice daily by oral route with 240 milliliters of water.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-05
Primary Completion
2011-01-27
Completion
2011-01-27

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 NCT01267006 on ClinicalTrials.gov