Clinical trial NCT01120314: Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
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, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Primary Objective:

* To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of Otamixaban.

Secondary Objective:

* To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

Detailed description: The study period for one subject is broken down as follows:

* 2 to 28 days of screening,
* 1 day of treatment,
* 8 to 11 days of follow-up after start of infusion.

There are 5 days in the unit starting the day before the start of infusion.

Eligibility criteria: Inclusion criteria:

* Subject with renal impairment:

  * Mild, moderate or severe renal impairment defined as Creatinine Clearance (CrCl) from 50 to 80, 30 to 50 and \< 30 mL/min respectively, based on the Cockcroft-Gault formula,
  * Body weight between 50.0 kg and 115.0 kg inclusive if male, between 40.0 kg and 95.0 kg inclusive if female, Body Mass Index between 18.0 and 34.9 kg/m2 inclusive.
  * Stable chronic renal impairment as defined by Cockcroft-Gault formula,
  * Vital signs, cardiac function and laboratory parameters within the acceptable range.
* Or matched subject (by age, gender and body weight) with normal renal function (defined as CrCl \>80 mL/min) and certified as healthy by physical examination, medical history and laboratory findings.
* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.

Exclusion criteria:

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.
* Active hepatitis, hepatic insufficiency.
* Acute renal failure, nephrotic syndrome.
* History of or current hematuria of urologic origin.
* Subject requiring dialysis during the study.
* History or presence of drug or alcohol abuse within two years before inclusion.
* Smoking more than 15 cigarettes or equivalent per day.
* 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.

Primary outcomes:
measure: Pharmacokinetics of Otamixaban (Observed concentration at the end of the infusion (Ceoi) and Areas Under the plasma concentration Curve(AUClast and AUC))
timeFrame: 4 days
Secondary outcomes:
measure: Pharmacodynamic effect based on coagulation parameters (activated Partial Prothrombin Time (aPTT), Prothrombin Time (PT) and International Normalized Ratio (INR))
timeFrame: 4 days
Other outcomes:
Locations:
city: Miami Gardens
country: United States
facility: Investigational Site Number 840003
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840005
state: Florida
city: St. Paul
country: United States
facility: Investigational Site Number 840004
state: Minnesota
city: Knoxville
country: United States
facility: Investigational Site Number 840002
state: Tennessee
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: