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

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ClinicalTrials.gov Identifier: NCT00419237
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Asthma Drug: GW685698X Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 13, 2005
Primary Completion Date : April 15, 2005
Study Completion Date : April 15, 2005
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Healthy subjects
Subjects with normal liver function test will be administered a single oral inhaled dose of 400 micrograms (mcg) GW685698X in the morning of the study day. Each healthy subject will be matched as closely as possible for age, gender, bodyweight and race to a subject with impaired liver function.
Drug: GW685698X
GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.
Experimental: Subjects with hepatic impairment
Subjects with Child Pugh B hepatic dysfunction will be administered a single oral inhaled dose of 400 mcg GW685698X in the morning of the study day.
Drug: GW685698X
GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.


Outcome Measures

Primary Outcome Measures :
  1. 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 [ Time Frame: Up to Day 13 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Up to Day 13 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419237


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFA10013
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00419237     History of Changes
Other Study ID Numbers: FFA10013
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
hepatic impairment pharmacokinetics

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases