Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 1048 MS - low dose; Drug: BIBR 1048 MS + Pantoprazole; Drug: BIBR 1048 MS - high dose

• Registration Number: NCT02170740
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Primary Completion: 2000-01
• 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: Male
• Target Recruitment: 26

Inclusion Criteria

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with GCP and local legislation
• Age ≥ 18 and ≤ 50 years
• Broca ≥ - 20% and ≤ + 20%

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Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• History of any bleeding disorder including prolonged or habitual bleeding
• History of other hematologic disease
• History of cerebral bleeding (e.g. after a car accident)
• History of commotio cerebri
• Intake of drugs with a long-life (> 24 hours) within 1 month prior to administration
• Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with investigational drug within 2 months prior to administration or during the trial
• Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (> 60g/day)
• Drug abuse
• Blood donation within 1 month prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the clinically accepted reference range
• History of any familiar bleeding disorder
• Thrombocytes < 150000/µl

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIBR 1048 MS + Pantoprazole	BIBR 1048 MS + Pantoprazole	-
BIBR 1048 MS	BIBR 1048 MS - low dose	-
BIBR 1048 MS	BIBR 1048 MS - high dose	-
BIBR 1048 MS + Pantoprazole	BIBR 1048 MS - high dose	-

Primary Outcome Measures

Name	Time	Method
Urinary excretion of total BIBR 953 ZW	Day 1, day 2, day 3 (different time points)
Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval	Day 1, day 2, day 3 (different time points)
Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW	Day 1, day 2, day 3 (different time points)
Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW	Day 1, day 2, day 3 (different time points)

Secondary Outcome Measures

Name	Time	Method
Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW	Day 1, day 2, day 3 (different time points)
Occurence of adverse events	6 weeks
Change from Baseline in pulse rate	Baseline, day 1,day 2, day 3, day 4
Change from Baseline in systolic and diastolic blood pressure	Baseline, day 1,day 2, day 3, day 4
Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration	Day 1, day 2, day 3 (different time points)
Change from Baseline in clinical laboratory tests	Baseline, day 1,day 2, day 3, day 4
Changes from baseline in activated partial thromboplastin time (aPTT)	Day 1, day 2, day 3 (different time points)
Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))	Day 1, day 2, day 3 (different time points)
Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration	ay 1, day 2, day 3 (different time points)