| Trial ID: | L5814 |
| Source ID: | NCT01607385
|
| Associated Drug: |
Gsk2330672
|
| Title: |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic a Single Day of Dosing With GSK1614235.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GSK2330672|DRUG: Placebo|DRUG: GSK1614235
|
| Outcome Measures: |
Primary: Adverse events, 3 weeks|Clinical laboratory tests for safety., Regular clinical chemistry and hematology panels., 7 weeks|Bristol Stool Form Scale, Frequency of bowel movements and quality of stool samples., 2 weeks|Gastrointestinal Symptom Rating Scale, Tolerability of possible gastic side effets., 2 weeks | Secondary: Pharmacokinetic measures of GSK2330672., AUC, Cmax, tmax, t1/2, Change from baseline at 2 weeks.|Pharmcokinetic measures of GSK2330672, GSK1614235, GSK2313533, and GSK2313537., AUC, Cmax, tmax and t1/2, Full profiles on Day 13.
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-05-18
|
| Completion Date: |
2012-12-03
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-26
|
| Locations: |
GSK Investigational Site, Baltimore, Maryland, 21225, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01607385
|
