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31001074/paroxetine

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 8, 2014

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
UNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01159821A Drug Interaction Study of 31001074 and Paroxetine in Healthy VolunteersPHASE1 COMPLETED 14 — — Aug 1, 2010Oct 1, 2010Apr 8, 20141 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameters (area under the plasma concentration-time curve [AUC] and the maximum plasma concentration [Cmax]) of 31001074 with and without the coadministration of paroxetine
0 to 72 hours after study drug administration on Day 1 and Day 13
Secondary Endpoints
The number and type of adverse events and serious adverse events reported
From screening (up to 29 days before study drug administration) through 30 days after Day 16 (study completion) or at the time of early withdrawal from the study
Results from clinical laboratory tests performed
During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
Findings from electrocardiograms (ECGs) and vital signs measurements performed
During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
001EXPERIMENTAL31001074/paroxetine 1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
Interventions
NameTypeDescription
31001074/paroxetineDRUG1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have a body mass index (BMI) (weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg * Have a blood pressure after the healthy volunteer is supine \[ie, lying down face up\] for 5 minutes between 90 and 140 mmHg systolic, inclusi...

Countries:United States
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