NCT00908154

Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.

Single-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802 and Its Interaction With Food in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models. This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. In addition, the effect of food on the pharmacokinetics of GSK1014802 will be investigated.

Detailed description

This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.

Conditions

• Bipolar Depression
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Tablets to match GSK1014802
DRUG	GSK1014802	Sodium channel blocker

Timeline

• Start date: 2008-05-31
• Primary completion: 2008-12-31
• Completion: 2008-12-31
• First posted: 2009-05-25
• Last updated: 2017-10-30

Locations

1 site across 1 country: United Kingdom