Clinical Trial Details
Trial ID: | L6877 |
Source ID: | NCT00501397 |
Associated Drug: | Ketoconazole |
Title: | A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers |
Acronym: | |
Status: | COMPLETED |
Study Results: | NO |
Results: | |
Conditions: | Type 2 Diabetes Mellitus|Diabetes Mellitus, Type 2 |
Interventions: | DRUG: ketoconazole|DRUG: GSK189075 |
Outcome Measures: | Primary: Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3, at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume|urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3., at Day 1 Session 1, Days 5 & 6 Session 3. | Secondary: Adverse events: all visits, all visits|ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3, Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3|Labs:followup, followup|Urine: Day 1 Session 1,Days 5-6 Session 3, Day 1 Session 1,Days 5-6 Session 3|Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup, Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup |
Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
Gender: | ALL |
Age: | ADULT |
Phases: | PHASE1 |
Enrollment: | 22 |
Study Type: | INTERVENTIONAL |
Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
Start Date: | 2007-02 |
Completion Date: | |
Results First Posted: | |
Last Update Posted: | 2012-06-04 |
Locations: | GSK Investigational Site, Columbus, Ohio, 43212, United States |
URL: | https://clinicaltrials.gov/show/NCT00501397 |