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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

Tracking Information
First Submitted Date  ICMJE May 17, 2010
First Posted Date  ICMJE May 19, 2010
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
  • PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z [ Time Frame: Day 1 to Day 4 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01126086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild and Moderate Hepatic Impairment
Official Title  ICMJE 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.
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatic Impairment
Intervention  ICMJE Drug: otamixaban XRP0673

Pharmaceutical form: solution for injection

Route of administration: intravenous

Study Arms  ICMJE
  • Experimental: Mild impairment
    Patients with mild hepatic impairment
    Intervention: Drug: otamixaban XRP0673
  • Experimental: Moderate impairment
    Patients with moderate impairment
    Intervention: Drug: otamixaban XRP0673
  • Experimental: Healthy subjects
    Matched healthy subjects
    Intervention: Drug: otamixaban XRP0673
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2010)
24
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01126086
Other Study ID Numbers  ICMJE POP6207
U1111-1116-8891 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP