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mipomersen; warfarin

Phase 1

Healthy | Small molecule | Other |Ionis Pharmaceuticals, Inc.|Last Updated: Aug 3, 2016

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

mipomersen; warfarin · 1 trial · 1 indication

Phase 1 1
NCT01133366A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose WarfarinHealthy
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin
Healthy
NCT0113336618
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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 to 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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Frequently asked questions about mipomersen; warfarin

What is mipomersen used for?

Mipomersen is an investigational small molecule being studied in healthy volunteers. A completed Phase 1 trial examined the effects of multiple doses of mipomersen (200 mg subcutaneous) on the pharmacodynamics and pharmacokinetics of a single dose of warfarin. The study enrolled 18 participants in the United States.

Who makes mipomersen?

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) is developing mipomersen. The company conducted a Phase 1 clinical trial of the drug in healthy volunteers in the United States.

What phase is mipomersen in?

Mipomersen is in Phase 1 clinical development. A single Phase 1 study has been completed, and there are no active trials currently listed. The drug remains investigational and has not been approved for any use.

What clinical trials is mipomersen in?

Mipomersen has one completed clinical trial, NCT01133366, titled 'A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin.' The Phase 1 study enrolled 18 healthy adults in the United States.

Is mipomersen the same as warfarin?

No, mipomersen and warfarin are different drugs. Mipomersen is the investigational drug being studied, while warfarin is the active control used in the clinical trial. The study examined how mipomersen affects the pharmacodynamics and pharmacokinetics of a single dose of warfarin.