Protocol Summary for FFA10013
| Protocol Id: | FFA10013 |
| Secondary Ids: |
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| 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. |
| Phase: | phase 1 |
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| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| 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 |
| Detailed Description: | |
| Record Verification Date: | July 2010 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | January 2005 |
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| Primary Purpose: | treatment |
| Allocation: | Non-randomized |
| Masking: | Open Label |
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| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Pharmacodynamics Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | 70 Year |
| Enrollment: | 20 |
| Enrollment Type: | |
| Healthy Volunteers?: | yes |
| Central Contact: | US GSK Clinical Trials Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | EU GSK Clinical Trials Call Center |
| Backup Central Contact Phone: | +44 (0) 20 8990 4466 |
| Backup Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria