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Ortho Tri-Cyclen

Phase 1

Hepatitis C Virus | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01063023Drug Interaction Oral Contraceptive Pill (OCP)PHASE1 COMPLETED 20 — — Jan 1, 2010Jun 1, 2010Jan 25, 20111 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
24 hours of dosing
Secondary Endpoints
To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered
Safety will be assessed through day 78
To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination
PK assessments will be done on Day 49, 50, 77 and 78
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Arm A - Ortho Tri-Cyclen®ACTIVE_COMPARATOR1 to 28 days
Arm B - Ortho Tri-Cyclen®ACTIVE_COMPARATOR29 to 56 days
Arm C - Ortho Tri-Cyclen® + BMS-650032ACTIVE_COMPARATOROrtho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days
Interventions
NameTypeDescription
Ortho Tri-Cyclen®DRUGTablets, Oral, 1 Tablet, once daily
BMS-650032DRUGTablets, Oral, 600 mg, BID
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Eligibility Criteria
Age Range18 Years — 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug Exclusion Criteria: * Abnormal pap smear within 1 year prior to day 1 * Any significant or chronic...

Countries:United States
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