| Trial ID: | L5338 |
| Source ID: | NCT00437606
|
| Associated Drug: |
Gk Activator (2)
|
| Title: |
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GK Activator (2)|DRUG: Ethanol
|
| Outcome Measures: |
Primary: AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose., Days 1, 8 and 15 | Secondary: tmax, AUC0-6, AUC0-last, t1/2, CL/F, Ac, CL for GK Activator (2) and M4. Cmin, Cmax, tmax and tmin of plasma glucose., Days 1, 8 and 15|AEs, laboratory parameters., Throughout study
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
2
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-03
|
| Completion Date: |
2007-06
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-24
|
| Locations: |
Berlin, Germany|Kiel, Germany|Bratislava, Slovakia
|
| URL: |
https://clinicaltrials.gov/show/NCT00437606
|
