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

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00419237
Enrollment
20
Registered
2007-01-08
Start date
2005-01-13
Completion date
2005-04-15
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

hepatic impairment pharmacokinetics

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

Interventions

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

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
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 dosingUp to Day 13

Secondary

MeasureTime frame
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 signsUp to Day 13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026