drugset / Trial / NCT00743405

Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

NCT00743405 ↗

Phase 1 Completed 30 enrolled GlaxoSmithKline
RandomizedCrossoverSingle-blindTreatment

Summary

This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.

Timeline

Start
2008-05-02
Primary completion
2008-12-15
Completion
2008-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1034702 Small molecule 0.5 mg Oral
Subject GSK1034702 Small molecule 5 mg Oral

Indications