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

NCT01126086 | Completed Phase 1

• 2 other identifiers: POP6207U1111-1116-8891
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety based on treatment-emergent adverse events, clinical laboratory evaluations, vital signs, and ECG

  Screening (-28 days) up 8 to 11 days after treament

Study Arms (3)

Mild impairment

EXPERIMENTAL

Patients with mild hepatic impairment

Drug: otamixaban XRP0673

Moderate impairment

EXPERIMENTAL

Patients with moderate impairment

Drug: otamixaban XRP0673

Healthy subjects

EXPERIMENTAL

Matched healthy subjects

Drug: otamixaban XRP0673

Interventions

otamixaban XRP0673 DRUG

Pharmaceutical form: solution for injection Route of administration: intravenous

Healthy subjects; Mild impairment; Moderate impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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
• Smoking more than 15 cigarettes or equivalent per day, unable to refrain from smoking during the institutionalization
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 840003

Miami Gardens, Florida, 33169, United States

Location

Investigational Site Number 840001

Orlando, Florida, 32809, United States

Location

Investigational Site Number 840002

Knoxville, Tennessee, 37920, United States

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

US (3)