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Raltegravir

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 4, 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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00518297DDI HV (ATV - Merck)PHASE1 COMPLETED 22Aug 1, 2007Dec 1, 2007Feb 4, 20101 United States
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Study Endpoints
Primary Endpoints
Safety Assessments
Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge
Pharmacokinetic Assessments
Days 5, 12, and 26
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RaltegravirDRUGTablet, Oral, 400 mg, twice daily for 5 Days
AtazanavirDRUGCapsule, Oral, 300 mg, twice daily for 7 Days
Atazanavir + RaltegravirDRUGCapsule/Tablet, Oral, 300/400, twice daily for 14 Days
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m² * Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a ...

Countries:United States
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