drugset / Trial / NCT01361646
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
RandomizedParallel-groupDouble-blindTreatment
Summary
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.
Timeline
- Start
- 2011-06
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tigulixostat | Small molecule | 10 mg | — |
| Subject | Tigulixostat | Small molecule | 25 mg | — |
| Subject | Tigulixostat | Small molecule | 50 mg | — |
| Subject | Tigulixostat | Small molecule | 100 mg | — |
| Subject | Tigulixostat | Small molecule | 200 mg | — |
| Subject | Tigulixostat | Small molecule | 400 mg | — |
| Subject | Tigulixostat | Small molecule | 600 mg | — |
| Subject | Tigulixostat | Small molecule | 800 mg | — |