drugset
drugset / Trial / NCT01494636

The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects

NCT01494636 ↗

Phase 1 Completed 31 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The study is split into two parts. Part A will assess the safety and tolerability of the new drug. Part B will assess safety and tolerability as well as the effect of GSK2339345 on induced cough.

Timeline

Start
2011-10-17
Primary completion
2012-03-15
Completion
2012-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2339345 Small molecule 3 ug Oral
Subject GSK2339345 Small molecule 6 ug Oral
Subject GSK2339345 Small molecule 15 ug Oral
Subject GSK2339345 Small molecule 25 ug Oral
Subject GSK2339345 Small molecule 30 ug Oral
Subject GSK2339345 Small molecule 60 ug Oral
Subject GSK2339345 Small molecule 100 ug Oral
Subject GSK2339345 Small molecule 120 ug Oral
Subject GSK2339345 Small molecule 250 ug Oral
Subject GSK2339345 Small molecule 1000 ug Oral
Subject GSK2339345 Small molecule 2000 ug Oral
Background Lidocaine Other / unclassified 40 mg Inhaled

Indications

No indication recorded.