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GSK drug

Phase 1

Bipolar Disorder | Small molecule | Psychiatry |Biogen Inc.|Last Updated: Oct 26, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00488566GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy VolunteersPHASE1 COMPLETED 50May 31, 2007May 31, 2008Oct 26, 20172 United Kingdom
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Study Endpoints
Primary Endpoints
Part1:AEs for the duration of the study;
duration of the study
ECG,vitals and MAO activity predose and upto 48h post dose;
predose and upto 48h post dose
clinical labs predose and upto 24h post dose.
predose and upto 24h post dose
PK parameters up to 48h post dose.
up to 48h post dose
Part2:Difference in rMT between pre-and post-dose and relationship with PK.
between pre-and post-dose and relationship with PK
Secondary Endpoints
Part1:Bond-Lader and body sway predose and upto 24h postdose.
predose and upto 24h postdose
Part2:AEs for the duration of the study;.
duration of the study
ECG,vitals and MAO activity predose and upto 48h postdose;
predose and upto 48h postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1OTHERSingle dose escalation
Part 2OTHERPharmacodynamic assessment
Interventions
NameTypeDescription
GSK drugDRUGGSK drug
PlaceboOTHERPlacebo
LamictalOTHERPositive control
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Part 1 Inclusion Criteria: * Healthy male subjects aged between 18 and 65 yrs and female (of non-child bearing potential) subjects aged between 18 and 50 years. Part 2 Inclusion Criteria: * right-handed healthy male subjects aged between 18 and 65 years. Parts 1 \& 2 Inclusion Criteria: * body ...

Countries:United Kingdom
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