Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery

Phase 2

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: BIBR 1048 capsule

• Registration Number: NCT02170935
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2002-06
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patients scheduled to undergo a primary elective total hip replacement
• Male or female being 18 years or older (women of child bearing potential may not be included)
• Patients weighing at least 40 kg
• Written informed consent for participation

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Exclusion Criteria

• Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke
• Known renal disease
• Known liver disease, alcohol or drug misuse
• Known malignancy
• Treatment with another study drug in the past month

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIBR 1048 capsule	BIBR 1048 capsule	-

Primary Outcome Measures

Name	Time	Method
time of last measureable BIBR 953 ZW plasma concentration (Tf)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
maximum plasma concentration (Cmax)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time to maximum plasma concentration (Tmax)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
terminal elimination constant	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
total clearance of drug from plasma	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time extrapolated to infinity (AUC0-infinity)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time curve until Tf (AUC0-Tf)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events	up to 24 hours after drug administration