drugset / Trial / NCT00437606
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Timeline
- Start
- 2007-03
- Primary completion
- 2007-06
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 40 g | Oral |
| Subject | GK Activator (2) | Unknown | 100 mg | Oral |