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

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.