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mipomersen ; warfarin

Phase 1

Healthy | Small molecule | Other |Ionis Pharmaceuticals, Inc.|Last Updated: Aug 3, 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
ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01133366A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose WarfarinPHASE1 COMPLETED 18 — — May 1, 2010Jul 1, 2010Aug 3, 20161 United States
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Study Endpoints
Primary Endpoints
Area under the effect curve (AUC), for INR (international normalized ratio), PT (prothrombin time), and aPTT (activated partial thromboplastin time)
Serial sampling up to 144 hours post dose
Maximal Value (MAX) for INR, PT and aPTT
Serial sampling up to 144 hours post dose
Time of maximal effect (Tmax) for INR, PT, and aPTT
Serial sampling up to 144 hours post dose
Secondary Endpoints
Warfarin Plasma Pharmacokinetic parameters (AUC 0-t, AUC 0-inf, Maximum Concentration (Cmax))
Serial PK sampling up to 144 hours post dose
Mipomersen Plasma Pharmacokinetic parameters (AUC0-t, AUC0-inf, Cmax)
Serial PK sampling up to 24 hours post dose
Incidence of treatment-emergent Adverse Events
Through Day 78
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
warfarin aloneACTIVE_COMPARATOR -
warfarin with mipomersenEXPERIMENTAL -
Interventions
NameTypeDescription
warfarin sodiumDRUG25 mg of warfarin oral (single dose)
mipomersen sodium; warfarin sodiumDRUG200 mg of mipomersen subcutaneous (SC) (4 doses) plus a single 25 mg of warfarin oral administered with the final mipomersen SC dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Written informed consent before any study-related procedure is performed. * Body mass index (BMI) between 18 and 32 kg/m2, inclusive. * No clinically significant abnormalities based on medical history, laboratory assessments, vital sign, 12-lead electrocardiogram (ECG) results...

Countries:United States
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