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mipomersen; warfarin

Phase 1

Undisclosed | RNA therapy | Other |Ionis Pharmaceuticals, Inc.|Trials Updated: Aug 3, 2016

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

mipomersen; warfarin clinical trials

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?

Mipomersen is an RNA therapy developed by Ionis Pharmaceuticals, Inc. (ticker: IONS). It has been studied in a Phase 1 clinical trial in healthy volunteers. The trial, NCT01133366, evaluated the effects of multiple doses of mipomersen on the pharmacodynamics and pharmacokinetics of single-dose warfarin.

Who is developing mipomersen?

Mipomersen is being developed by Ionis Pharmaceuticals, Inc., which trades under the ticker IONS. The company sponsored the Phase 1 trial NCT01133366, a study of mipomersen in healthy volunteers.

What phase is mipomersen in?

Mipomersen is in Phase 1 clinical development. One Phase 1 trial, NCT01133366, has been completed. That trial enrolled 18 healthy volunteers and was an active-controlled study evaluating multiple doses of mipomersen (200 mg SC) and single-dose warfarin.

What clinical trials is mipomersen in?

Mipomersen has been studied in one 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 trial was completed, enrolled 18 healthy volunteers in the United States, and was active-controlled.

Is mipomersen the same as mipomersen sodium?

Yes, mipomersen is also known as mipomersen sodium. Similarly, warfarin is also known as warfarin sodium. These alternative names refer to the same compounds.

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