| Trial ID: | L3790 |
| Source ID: | NCT00823940
|
| Associated Drug: |
Gsk1362885
|
| Title: |
A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GSK1362885|DRUG: GSK1362885|DRUG: Glucagon|DRUG: Glucagon + GSK1362885
|
| Outcome Measures: |
Primary: Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs, During the duration of study participation (from 2 days up to 5 weeks)|Pharmacokinetic parameters: AUC, Cmax, Tmax, t1/2, tlag, Cl/F, and V/F, 24 - 48 hours following each dose | Secondary: Pharmacokinetic parameters to assess dose proportionality and food effect, 24 - 48 hours following each dose|Pharmacodynamic parameters may include change from baseline in glucose, insulin, C-peptide and AUC following administration of IV glucagon in a standardized GC test with and without prior administration of GSK1362885, 24 - 48 hours following each dose
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-01-13
|
| Completion Date: |
2009-04-27
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-07
|
| Locations: |
GSK Investigational Site, Minneapolis, Minnesota, 55404, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00823940
|
