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JNJ-31001074; ketoconazole

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 30, 2010

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
NCT00915746A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy VolunteersPHASE1 COMPLETED 14 — — Nov 1, 2009Dec 1, 2009Apr 30, 2010 - —
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Study Endpoints
Primary Endpoints
The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers
Multiple blood samples will be obtained over the 11 day open-label treatment phase
Secondary Endpoints
To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole
up to 32 days (including a 21 day screening phase)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Interventions
NameTypeDescription
JNJ-31001074; ketoconazoleDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * healthy volunteer between the ages of 18-55 * if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test * body mass index between 18-30 * body weight greater than or equal to 50 kilograms * blood pressure b...

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