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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT01120314

Run by

Sanofi

People needed

48

Starts

2010-04-01

Expected to finish

2011-07-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840003 — Miami Gardens, Florida, United States
• Investigational Site Number 840005 — Orlando, Florida, United States
• Investigational Site Number 840004 — Saint Paul, Minnesota, United States
• Investigational Site Number 840002 — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.