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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: OTAMIXABAN (XRP0673)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120314

POP6537

U1111-1116-5821 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Severe renal impairment population

Experimental group

Treatment:

Drug: OTAMIXABAN (XRP0673)

Moderate renal impairment population

Experimental group

Treatment:

Drug: OTAMIXABAN (XRP0673)

Mild renal impairment population

Experimental group

Treatment:

Drug: OTAMIXABAN (XRP0673)

Healthy population

Experimental group

Description:

Healthy matched subjects

Treatment:

Drug: OTAMIXABAN (XRP0673)