| Trial ID: | L4419 |
| Source ID: | NCT00607906
|
| Associated Drug: |
Sb-756050 Immediate Release Capsule
|
| Title: |
First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: SB-756050 immediate release capsule|DRUG: SB-756050 modified release capsule|DRUG: Placebo
|
| Outcome Measures: |
Primary: adverse events:, each visit|clinical laboratory:, day -1, day 2 each period|electrocardiogram (ECG):, day 1 each period|vital signs assessments:, day -1, day 1 each period | Secondary: plasma drug concentrations:, Day 1 each dosing level|plasma blood sugar & other parameter concentrations:, Day 1 Period 4 following meal|Correlation between drug concentrations & blood sugar levels:, day 1 period 4
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: |Primary Purpose: TREATMENT
|
| Start Date: |
2007-11-16
|
| Completion Date: |
2008-03-10
|
| Results First Posted: |
|
| Last Update Posted: |
2017-09-06
|
| Locations: |
GSK Investigational Site, Minneapolis, Minnesota, 55404, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00607906
|
