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otamixaban XRP0673

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Sanofi|Last Updated: May 8, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

otamixaban XRP0673 · 1 trial · 1 indication

Phase 1 1
NCT01126086Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic ImpairmentHepatic Impairment
COMPLETED25 Analytics
PHASE1COMPLETED
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
Hepatic ImpairmentUnlock trial analytics

Study Endpoints

Primary Endpoints

PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z
Day 1 to Day 4
Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)
Screening (-28 days) up to 4 days after treatment

Secondary Endpoints

Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG
Screening (-28 days) up 8 to 11 days after treament
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mild impairmentEXPERIMENTALPatients with mild hepatic impairment
Moderate impairmentEXPERIMENTALPatients with moderate impairment
Healthy subjectsEXPERIMENTALMatched healthy subjects

Interventions

NameTypeDescription
otamixaban XRP0673DRUGPharmaceutical form: solution for injection Route of administration: intravenous
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: \- Subjects with hepatic impairment: * Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 100.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive * Stable chronic liver disease assessed by medical history, physical examin...

Countries:United States
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Frequently asked questions about otamixaban XRP0673

What is otamixaban XRP0673 used for?

Otamixaban XRP0673 is an investigational small molecule being studied for use in patients with mild and moderate hepatic impairment. It is being developed by Sanofi (SNY) and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation.

Who makes otamixaban XRP0673?

Otamixaban XRP0673 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical development for hepatic impairment.

What phase is otamixaban XRP0673 in?

Otamixaban XRP0673 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study in patients with hepatic impairment has been completed.

What clinical trials is otamixaban XRP0673 in?

Otamixaban XRP0673 has one completed Phase 1 clinical trial, identified as NCT01126086. This study evaluated the pharmacokinetics, pharmacodynamics, and tolerability of otamixaban in patients with mild and moderate hepatic impairment. The trial enrolled 25 participants in the United States.

Is otamixaban XRP0673 the same as XRP0673?

Yes, otamixaban XRP0673 is also known as XRP0673. Both names refer to the same investigational drug being developed by Sanofi for hepatic impairment. The drug is currently in Phase 1 clinical development.