- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02254070
Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BIBT 986 BS in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment
September 30, 2014 updated by: Boehringer Ingelheim
Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of 1.0 mg of BIBT 986 BS Given as a Single Dose Infusion Over 30 Minutes in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment in an Open, Group Comparison Design
To assess the influence of different degrees of renal impairment on safety, tolerability, pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose infusion over 30 minutes in comparison to a normal renal function
Study Overview
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female subjects determined by results of screening with a creatinine clearance >80 mL/min (Group 1)
Renally impaired male or female subjects determined by results of screening with the following creatinine clearance results:
- creatinine clearance 51-80 mL/min (Group 2)
- creatinine clearance 31-50 mL/min (Group 3)
- creatinine clearance ≤ 30 mL/min (Group 4)
- subjects requiring hemodialysis (Group 5)
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and <=75 years
- BMI >=18.5 and <=29.9 kg/m2 for Groups 1+2
- BMI >=18.5 and <=32 kg/m2 for Groups 3, 4 and 5
Exclusion Criteria:
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
- Abnormal PT, TT, aPTT (must be within the normal range after no more than one repeated test), thrombocytes < 150000/μl (two repeats of the first test)
- Evidence of haematuria either macroscopically detectable or microscopic on urinalysis (normal microscopic results after no ore than one repeated test)
- Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, CNS trauma, retinopathy, nephrolithiasis)
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of central nervous system (CNS) or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
- Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study examination
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- For women with childbearing potential: no reliable contraception (accepted methods are intra uterine device, hormonal contraceptives, bilateral tubal ligation, hysterectomy, condoms) or pregnancy (known or detected by a positive pregnancy test) or breast feeding period
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
- Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 ml, < 1 month prior to administration or during the trial
- Excessive physical activities < 5 days prior to administration of study drug or during trial
- Clinically relevant laboratory abnormalities
- Veins unsuited for i.v. puncture and administration of prolonged infusions on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
Renally impaired subjects (Group 2, 3, 4 and 5) who meet any of the following criteria will not be entered into this trial:
- Moderate and severe concurrent liver function impairment (e.g., due to hepatorenal syndrome)
- Gastrointestinal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells or blackouts
- Abnormal values for PT, TT, aPTT and thrombocytes considered by the investigator or one of the co-investigators to be clinically relevant
- Hemoglobin concentration <9 mg/dl
- Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta,CNS trauma, retinopathy, nephrolithiasis) considered by the investigator or one of the co-investigators to be clinically relevant
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
- Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study examination
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- For women with childbearing potential: no reliable contraception (accepted methods are intra uterine device, hormonal contraceptives, bilateral tubal ligation, hysterectomy, condoms) or pregnancy (known or detected by a positive pregnancy test) or breast feeding period
- Faecal occult blood (FOB) in 1 of 3 subsequent samples collected for the pre-study examination
- Use of any drugs which have an influence on the blood clotting within 14 days prior to administration or during the trial (except heparin for hemodialysis patients)
- Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
- Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation or loss > 400 ml, < 1 month prior to administration or during the trial
- Excessive physical activities < 5 days prior to administration of study drug or during trial
- Clinically relevant laboratory abnormalities
- Veins unsuited for i.v. puncture and administration of prolonged infusions on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIBT 986 BS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Terminal rate constant of the analyte in plasma (λz)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Time to reach the maximum concentration of the analyte in plasma (tmax)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Mean residence time of the analyte in the body after intravenous infusion (MRTinf)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Total clearance of the analyte from plasma following intravascular administration (CL)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Apparent volume of distribution at steady state following an intravascular dose (Vss)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Amount of drug excreted in the urine (Ae)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Change in activated partial thromboplastin time (aPTT)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Change in ecarin clotting time (ECT)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Change in International Normalized Ratio (INR)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Change in thrombin time (TT)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Plasma concentration of the analyte at the end of the intravenous infusion (CT)
Time Frame: 29 minutes after drug administration
|
29 minutes after drug administration
|
|
Number of participants with clinically significant changes in vital signs
Time Frame: Up to 3 days after drug administration
|
Blood pressure and pulse rate
|
Up to 3 days after drug administration
|
Number of participants with clinically significant changes in ECG (electrocardiogram)
Time Frame: Up to 3 days after drug administration
|
Up to 3 days after drug administration
|
|
Number of participants with abnormal changes in clinical laboratory parameters
Time Frame: Up to 3 days after drug administration
|
Up to 3 days after drug administration
|
|
Number of participants with adverse events
Time Frame: Up to 3 days after drug administration
|
Up to 3 days after drug administration
|
|
Change in prothrombin time (PT)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
partial area under the concentration time curve (from time 0 to last sampling time preceding hemodialysis in any of the patients) (AUCt1-t2)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
fraction of administered drug excreted unchanged in urine over the respective time interval (fe)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
|
Renal clearance of the analyte from plasma following intravascular administration (CLR)
Time Frame: Up to 48 hours after drug administration
|
Up to 48 hours after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
August 1, 2004
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
September 30, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1192.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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