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WellbutrinXL

Phase 1

Depressive Disorder | Small molecule | Other |GSK plc|Last Updated: Aug 10, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00439868A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular PressurePHASE1 COMPLETED 33Feb 16, 2007Jun 8, 2007Aug 10, 20171 United States
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Study Endpoints
Primary Endpoints
Intraocular pressure at Day -1, Days 1 & 14.
at Day -1, Days 1 & 14.
Secondary Endpoints
Intraocular pressure,Pupil diameter, anterior chamber angle
Days-1,1&14
Wellbutrin XL plasma level
Days1,12-14
adverse events
each visit
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Study Design & Arms
AllocationNON_RANDOMIZED
ModelCROSSOVER
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Treatment Group 1EXPERIMENTALSubjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks.
Treatment Group 2EXPERIMENTALSubjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD.
Interventions
NameTypeDescription
WellbutrinXLDRUGWELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
placeboDRUGMatching placebo tablets to WELLBUTRIN XL.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or females. * Non-smokers * Agree to remain in the clinic for the time defined in the protocol. * Normal ECG. Exclusion Criteria: * Any serious medical disorder or condition. * Any history of an endocrine disorder. * Any clinically significant laboratory abnorm...

Countries:United States
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