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Completed

NCT Number: NCT01126086

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

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.

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Key information

Conditions

Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 840003, Miami Gardens, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

otamixaban XRP0673

Drug

Pharmaceutical form: solution for injection

Route of administration: intravenous

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 19, 2010
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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