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