Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00419237

First received: January 5, 2007

Last updated: May 15, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2007

Last Updated Date

May 15, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To investigate how impaired liver function affects the movement of single dose inhaled drug GW685698X within the body. Blood exposure levels in patients and matched control patients compared by taking blood samples after dosing

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00419237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effect of GW685698X on serum cortisol by calculating weighted mean in blood over 24 hrs. Safety and tolerability of GW685698X in patients with impaired liver function from blood samples during dosing (clearance/distribution) and monitoring vital signs

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function

Official Title ^ICMJE

A Study to Investigate the Pharmacokinetics of a Single Inhaled Dose (400mcg) of GW685698X and Its Effect on Serum Cortisol in Patients With Impaired Liver Function and Matched Control Subjects.

Brief Summary

The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From the study results it should be possible to assess if there is an altered Risk: Benefit in patients with moderate hepatic impairment

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatic Impairment

Intervention ^ICMJE

Drug: GW685698X

Other Name: GW685698X

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion:

Are aged between 18-70 years, inclusive.
If Female, you must be incapable of becoming pregnant.
Show FEV1 of more than 70% of the predicted normal at screening.
Are able to correctly use a DISKUS at the screening visit.
Have Body Mass Index within the range of 19-33 kg/m2 inclusive.
Do not show a positive pre-study urine drug screen.
Do not show a positive pre-study blood alcohol test.
Demonstrate a clinically normal 12-lead ECG at screening.
Do not show a positive blood test for HIV.

If you are a Healthy Volunteer you must also:

Have no significant abnormality on clinical examination.
Have Liver Function Tests within the reference range at screening.

If you are a Patient Volunteer you must:

Have moderate hepatic impairment
Have no significant abnormality on clinical examination apart from hepatic impairment.

Exclusion:

Suffered an upper respiratory infection in the 4 weeks before the screening visit.
Suffered a lower respiratory infection in the 6 weeks before the screening visit.
Taken oral corticosteroids in the 8 weeks before the screening visit.
Taken inhaled, intranasal or topical steroids in the 4 weeks before the screening visit.
A prolonged heartbeat (QTc interval >470msec).
High blood pressure (systolic >160mmHg or diastolic >90mmHg) or as defined by the Investigator.
Known sensitivity to corticosteroids.
A history of lactose intolerance.
A history of severe milk protein allergy.
Donated blood in the last 3 months, or more than 1500mL (1000mL if female) in the last 12 months (including the amount taken for this study).
Participated in a clinical trial within the last 3 months where you are/were exposed to a drug or device.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00419237

Other Study ID Numbers ^ICMJE

FFA10013

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD MDsc FFPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top