Clinical trial NCT00419237: Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: hepatic impairment pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Up to Day 13
Secondary outcomes:
measure: 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
timeFrame: Up to Day 13
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: