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Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT01126086
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

- To study effect of mild and moderate hepatic impairment on the pharmacokinetics of otamixaban.

Secondary Objective:

- To assess the pharmacodynamic effects of otamixaban on subjects with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.


Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: otamixaban XRP0673 Phase 1

Detailed Description:
The duration of each part of the study for one subject was 28 days of screening, 1 day of treatment, with 5 days in the unit (Day -1 to Day 4) and a 8 to 11 days of follow-up after start of infusion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban Given as a Single 80 μg/kg Bolus Plus 100 μg/kg/h Continuous Infusion for 24 Hours in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function.
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Mild impairment
Patients with mild hepatic impairment
Drug: otamixaban XRP0673

Pharmaceutical form: solution for injection

Route of administration: intravenous


Experimental: Moderate impairment
Patients with moderate impairment
Drug: otamixaban XRP0673

Pharmaceutical form: solution for injection

Route of administration: intravenous


Experimental: Healthy subjects
Matched healthy subjects
Drug: otamixaban XRP0673

Pharmaceutical form: solution for injection

Route of administration: intravenous





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

Secondary Outcome Measures :
  1. Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG [ Time Frame: Screening (-28 days) up 8 to 11 days after treament ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 examination, laboratory values
  • Vital signs, cardiac function and laboratory parameters within the acceptable range for subjects with hepatic impairment
  • If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal
  • Patients with hepatic impairment will be matched to healthy subjects who are defined as healthy by physical examination, medical history and laboratory findings and are matched to patients with respect to age, gender, and body weight. Inclusion/exclusion criteria for healthy subjects may differ slightly from those listed for patients and are defined in the study protocol

Exclusion criteria:

  • Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness
  • Creatinine level above the upper limit of normal
  • Hepatocarcinoma
  • Acute hepatitis
  • Hepatic encephalopathy grade 2, 3 and 4
  • History or presence of drug or alcohol abuse within two years before inclusion
  • Smoking more than 15 cigarettes or equivalent per day, unable to refrain from smoking during the institutionalization
  • Any significant change in chronic treatment medication within 14 days before inclusion

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126086


Locations
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United States, Florida
Investigational Site Number 840003
Miami Gardens, Florida, United States, 33169
Investigational Site Number 840001
Orlando, Florida, United States, 32809
United States, Tennessee
Investigational Site Number 840002
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01126086     History of Changes
Other Study ID Numbers: POP6207
U1111-1116-8891 ( Other Identifier: UTN )
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Otamixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants