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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

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ClinicalTrials.gov Identifier: NCT02254070
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBT 986 BS Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2003
Actual Primary Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: BIBT 986 BS Drug: BIBT 986 BS



Primary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: Up to 48 hours after drug administration ]
  2. Time to reach the maximum concentration of the analyte in plasma (tmax) [ Time Frame: Up to 48 hours after drug administration ]
  3. Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞) [ Time Frame: Up to 48 hours after drug administration ]
  4. 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 ]
  5. Terminal rate constant of the analyte in plasma (λz) [ Time Frame: Up to 48 hours after drug administration ]
  6. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 48 hours after drug administration ]
  7. Mean residence time of the analyte in the body after intravenous infusion (MRTinf) [ Time Frame: Up to 48 hours after drug administration ]
  8. Total clearance of the analyte from plasma following intravascular administration (CL) [ Time Frame: Up to 48 hours after drug administration ]
  9. Apparent volume of distribution at steady state following an intravascular dose (Vss) [ Time Frame: Up to 48 hours after drug administration ]
  10. Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz) [ Time Frame: Up to 48 hours after drug administration ]
  11. Amount of drug excreted in the urine (Ae) [ Time Frame: Up to 48 hours after drug administration ]
  12. Change in activated partial thromboplastin time (aPTT) [ Time Frame: Up to 48 hours after drug administration ]
  13. Change in ecarin clotting time (ECT) [ Time Frame: Up to 48 hours after drug administration ]
  14. Change in International Normalized Ratio (INR) [ Time Frame: Up to 48 hours after drug administration ]
  15. Change in thrombin time (TT) [ Time Frame: Up to 48 hours after drug administration ]
  16. Plasma concentration of the analyte at the end of the intravenous infusion (CT) [ Time Frame: 29 minutes after drug administration ]
  17. Number of participants with clinically significant changes in vital signs [ Time Frame: Up to 3 days after drug administration ]
    Blood pressure and pulse rate

  18. Number of participants with clinically significant changes in ECG (electrocardiogram) [ Time Frame: Up to 3 days after drug administration ]
  19. Number of participants with abnormal changes in clinical laboratory parameters [ Time Frame: Up to 3 days after drug administration ]
  20. Number of participants with adverse events [ Time Frame: Up to 3 days after drug administration ]
  21. Change in prothrombin time (PT) [ Time Frame: Up to 48 hours after drug administration ]
  22. 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 ]
  23. fraction of administered drug excreted unchanged in urine over the respective time interval (fe) [ Time Frame: Up to 48 hours after drug administration ]
  24. Renal clearance of the analyte from plasma following intravascular administration (CLR) [ Time Frame: Up to 48 hours after drug administration ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.)
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254070    
Other Study ID Numbers: 1192.12
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases