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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419237
• Other study ID #: FFA10013
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2007
• Last updated: October 31, 2017
• Start date: January 13, 2005
• Est. completion date: April 15, 2005

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 15, 2005
• Est. primary completion date: April 15, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Up to Day 13
Secondary	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		Up to Day 13

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study FFA10013 can be found on the GSK Clinical Study Register.