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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01126086

Enrollment

Registered

2010-05-19

Start date

2010-05-31

Completion date

2011-04-30

Last updated

2014-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

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.

Interventions

DRUGotamixaban XRP0673

Pharmaceutical form: solution for injection Route of administration: intravenous

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PK parameters including Ceoi, AUClast, AUC, C1min, CL, Vss, and t1/2z	Day 1 to Day 4
Pharmacodynamic based on coagulation parameters, activated partial prothrombin time (aPTT), prothrombin time (PT), and international normalized ratio (INR)	Screening (-28 days) up to 4 days after treatment

Secondary

Measure	Time frame
Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG	Screening (-28 days) up 8 to 11 days after treament

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026