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

NCT ID: NCT00419237

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-13
• Study Completion Date: 2005-04-15

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

Conditions

Asthma

Keywords

hepatic impairment pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

GW685698X

Intervention Type: DRUG

GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.

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.

Group Type: EXPERIMENTAL

GW685698X

Intervention Type: DRUG

GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.

Interventions

GW685698X

GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

Germany

Study Documents

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

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Document Type: Individual Participant Data Set

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Document Type: Dataset Specification

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Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

FFA10013

Identifier Type: -

Identifier Source: org_study_id