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CYP and transporter probe substrates

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 13, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02578277Study on Effects of BMS-955176 on the Pharmacokinetics of Probe SubstratesPHASE1 COMPLETED 59Nov 9, 2015Dec 23, 2015Jul 13, 20181 United States
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Study Endpoints
Primary Endpoints
Cmax (maximum observed concentration)
Days 1 to 18
AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration
Days 1 to 18
AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time
Days 1 to 18
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Single sequence, 3-period DDI (drug-drug interaction)EXPERIMENTALSingle sequence
Interventions
NameTypeDescription
CYP and transporter probe substratesDRUGCocktail of CYP (cytochrome P450) and transporter probe substrates
BMS-955176DRUGBMS-955176
BMS-955176 plus CYP and transporter probe substratesDRUGBMS-955176 plus the cocktail of CYP and transporter probe substrates
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written Informed Consent 2. Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations 3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m...

Countries:United States
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