drugset / Trial / NCT01361646

Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

NCT01361646

Phase 1 Completed 129 enrolled LG Life Sciences
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

EvaluationDrugModalityDoseRoute
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

Indications