Status:
COMPLETED
Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 13 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00419237
Start Date
January 13 2005
End Date
April 15 2005
Last Update
November 6 2017
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