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GSK1014802

Phase 1

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

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

Clinical trial landscape

GSK1014802 · 2 trials · 3 indications

Phase 1 2
NCT00955396Study to Investigate the Effect of GSK1014802 on Ambulatory Blood PressureHealthy Volunteer
COMPLETED60 Analytics
NCT00908154Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.Bipolar Depression
COMPLETED51 Analytics
PHASE1COMPLETED
Study to Investigate the Effect of GSK1014802 on Ambulatory Blood Pressure
Healthy Volunteer
NCT0095539660
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PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
Bipolar Depression
NCT0090815451
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Study Endpoints

Primary Endpoints

Change in 24 h average SBP and DBP from Baseline to Day 36.
36 days
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

Change in 24 h average SBP and DBP from Baseline to Day 15. Change in average SBP and DBP within a dosing interval (12 h) from Baseline to Days 14 and 35.
35 days
Change in 24 h average SBP and DBP from Baseline to Days 15 and 36 in subjects with baseline SBP 120-139 mmHg and also DBP 80-89 mmHg.
36 days
Change in day-time outpatient (6:00 AM to 10:00 PM) SBP and DBP from Baseline to Days 15 and 36.
36 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

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

Interventions

NameTypeDescription
GSK1014802DRUGTablets
PlaceboDRUGTablets
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, liver function and cardiac monitoring. * A female subje...

Countries:United StatesUnited Kingdom
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Frequently asked questions about GSK1014802

What is GSK1014802 used for?

GSK1014802 is an investigational small molecule being studied for use in bipolar depression and in healthy volunteers. It is being developed by Biogen Inc. (BIIB). The drug is currently in Phase 1 clinical development and is not approved for any use.

Who makes GSK1014802?

GSK1014802 is being developed by Biogen Inc., which trades under the ticker BIIB. The drug is an investigational small molecule in Phase 1 clinical development for bipolar depression and healthy volunteer studies.

What phase is GSK1014802 in?

GSK1014802 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in bipolar depression and one in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is GSK1014802 in?

GSK1014802 has completed two Phase 1 trials. NCT00908154 studied repeat doses in bipolar depression and bipolar disorder in the United Kingdom. NCT00955396 studied the effect on ambulatory blood pressure in healthy volunteers in the United States.

Is GSK1014802 the same as any other drug?

GSK1014802 is the drug name used in clinical trials. No alternative names have been reported for this investigational compound. It is being developed by Biogen Inc. (BIIB) for bipolar depression and healthy volunteer studies.