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GSK1014802

Phase 1

Bipolar Depression | Small molecule | Psychiatry |Biogen Inc.|Trials Updated: Oct 30, 2017

GSK1014802 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

GSK1014802 clinical trials

GSK1014802 · 1 trial · 2 indications

Phase 1 1
NCT00908154Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.Bipolar Depression
COMPLETED51 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
Bipolar DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.
14-28 days
Blood concentrations of GSK1014802 following a single oral dose of GSK1014802.
1 day
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose.
14-28 days
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food.
14-28 days

Secondary Endpoints

Bond-Lader VAS scale
14-28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1OTHER -
Cohort 4OTHER -
Cohort 3OTHER -
Cohort 2OTHER -

Interventions

NameTypeDescription
PlaceboDRUGTablets to match GSK1014802
GSK1014802DRUGSodium channel blocker
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male or female (of non-child bearing potential) subjects aged between 18 and 55 years. * A female su...

Countries:United Kingdom
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Frequently asked questions about GSK1014802

What is GSK1014802?

GSK1014802 is an investigational small molecule being developed by Biogen Inc. for bipolar depression. It has completed a Phase 1 clinical trial evaluating its safety, tolerability, and pharmacokinetics in repeat doses. The drug is in early clinical development and is not approved for any indication.

What is GSK1014802 used for?

GSK1014802 is being studied for the treatment of bipolar depression, a condition associated with bipolar disorder. Its development is focused on psychiatric indications. The compound remains investigational and has not been approved for clinical use in bipolar depression or any other condition.

Who is developing GSK1014802?

Biogen Inc. (ticker: BIIB) is developing GSK1014802. The company is the sponsor behind the clinical program evaluating the compound in bipolar depression. Biogen is a biotechnology company focused on neurological and psychiatric disorders.

What phase is GSK1014802 in?

GSK1014802 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not received regulatory approval for bipolar depression or any other indication.

What clinical trials is GSK1014802 in?

GSK1014802 has been evaluated in one completed Phase 1 trial, NCT00908154, titled "Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802." The randomized, double-blind, controlled study enrolled 51 healthy volunteers in the United Kingdom. No active trials are currently listed for this compound.

Is GSK1014802 a small molecule drug?

Yes, GSK1014802 is a small molecule therapeutic. It is being developed as an orally available compound for psychiatric indications, specifically bipolar depression. Small molecule drugs are typically chemically synthesized and can often be administered orally, distinguishing them from biologic therapies.