Protocol Summary for 112648
| Protocol Id: | 112648 |
| Secondary Ids: |
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| Title: | An open-label, randomized, single sequence, two period study to assess the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of a single oral dose of GSK962040 in healthy volunteers |
| Phase: | phase 1 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | No |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CDER |
| IND/IDE Number: | 105366 |
| IND/IDE Serial Number: | |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a single dose of GSK962040. The results from this study will help to estimate the maximum increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also contain an exploratory investigation of biliary secretion of GSK962040 and or its metabolites. |
| Detailed Description: | |
| Record Verification Date: | April 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2009 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | November 2009 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | treatment |
| Allocation: | Randomized |
| Masking: | Open Label |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Single Group Assignment |
| Study Classification (Endpoint): | Pharmacokinetics/dynamics Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | 65 Year |
| Enrollment: | 20 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | |
| Backup Central Contact Phone: | |
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| 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: |
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information
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Click to view inclusion/exclusion criteria