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OC containing EE and NET

Phase 1

Arthritis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Dec 26, 2016

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02832180The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female SubjectsPHASE1 COMPLETED 25 — — May 1, 2016Oct 1, 2016Dec 26, 20162 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of EE and NET
Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve (AUC) of EE and NET
Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Area under the concentration-time curve over the dosing interval [AUC (TAU)] of EE and NET
Cycle 1 Day 21 to Cycle 2 Day 22 (30 days)
Secondary Endpoints
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death.
Cycle 1 Day 1 to Cycle 2 Day 25; For SAEs up to 30 days post discontinuation of dosing or participation.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Daily single dose of OC containing EE and NETEXPERIMENTALDaily single dose of OC Containing EE and NET alone.
Daily single dose of OC in combination with BMS-986142EXPERIMENTALDaily single dose of OC containing EE and NET in combination with BMS-986142.
Interventions
NameTypeDescription
OC containing EE and NETDRUG -
BMS-986142DRUG -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Signed Informed Consent * Target population: Healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests that are willing to switch...

Countries:United States
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Competitive Landscape -Arthritis 9 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH5PHASE4Undisclosed
Smith & Nephew plc Sponsored ADRSNN3PHASE4Undisclosed
Johnson & JohnsonJNJ1PHASE4Undisclosed
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