HealthyPhase 1NCT02254070
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
A Phase 1 study testing BIBT 986 BS in people with Healthy, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIBT 986 BS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Aug 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 47Show fewer
- 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.)
About this study
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
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
- Conditions
- Healthy
- Being tested
- BIBT 986 BS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBT 986 BSDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBT 986 BS | Experimental | Not described Receives: Drug: BIBT 986 BS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 48 hours after drug administration
Time to reach the maximum concentration of the analyte in plasma (tmax)
Measured: Up to 48 hours after drug administration
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Measured: 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)
Measured: Up to 48 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)
Measured: Up to 48 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: Up to 48 hours after drug administration
Mean residence time of the analyte in the body after intravenous infusion (MRTinf)
Measured: Up to 48 hours after drug administration
Total clearance of the analyte from plasma following intravascular administration (CL)
Measured: Up to 48 hours after drug administration
Apparent volume of distribution at steady state following an intravascular dose (Vss)
Measured: Up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an intravascular dose (Vz)
Measured: Up to 48 hours after drug administration
Amount of drug excreted in the urine (Ae)
Measured: Up to 48 hours after drug administration
Change in activated partial thromboplastin time (aPTT)
Measured: Up to 48 hours after drug administration
Change in ecarin clotting time (ECT)
Measured: Up to 48 hours after drug administration
Change in International Normalized Ratio (INR)
Measured: Up to 48 hours after drug administration
Change in thrombin time (TT)
Measured: Up to 48 hours after drug administration
Plasma concentration of the analyte at the end of the intravenous infusion (CT)
Measured: 29 minutes after drug administration
Number of participants with clinically significant changes in vital signs
Blood pressure and pulse rate
Measured: Up to 3 days after drug administration
Number of participants with clinically significant changes in ECG (electrocardiogram)
Measured: Up to 3 days after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to 3 days after drug administration
Number of participants with adverse events
Measured: Up to 3 days after drug administration
Change in prothrombin time (PT)
Measured: 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)
Measured: Up to 48 hours after drug administration
fraction of administered drug excreted unchanged in urine over the respective time interval (fe)
Measured: Up to 48 hours after drug administration
Renal clearance of the analyte from plasma following intravascular administration (CLR)
Measured: Up to 48 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJun 2003
- Primary completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254070
- Sponsor's protocol ID
- 1192.12
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02254070
- Acronym / sponsor ID
- 1192.12
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Aug 2004 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBT 986 BS | Experimental | Drug: BIBT 986 BS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (47 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBT 986 BS | Drug | BIBT 986 BS |
Primary outcome
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: 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
Total area under the plasma drug concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: 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
Terminal rate constant of the analyte in plasma (λz)
Time frame: 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
Mean residence time of the analyte in the body after intravenous infusion (MRTinf)
Time frame: 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
Apparent volume of distribution at steady state following an intravascular dose (Vss)
Time frame: 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
Amount of drug excreted in the urine (Ae)
Time frame: Up to 48 hours after drug administration
Change in activated partial thromboplastin time (aPTT)
Time frame: Up to 48 hours after drug administration
Change in ecarin clotting time (ECT)
Time frame: Up to 48 hours after drug administration
Change in International Normalized Ratio (INR)
Time frame: Up to 48 hours after drug administration
Change in thrombin time (TT)
Time frame: 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
Number of participants with clinically significant changes in vital signs
Time frame: Up to 3 days after drug administration
Blood pressure and pulse rate
Number of participants with clinically significant changes in ECG (electrocardiogram)
Time frame: 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
Number of participants with adverse events
Time frame: Up to 3 days after drug administration
Change in prothrombin time (PT)
Time frame: 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
fraction of administered drug excreted unchanged in urine over the respective time interval (fe)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIBT 986 BS in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum measured concentration of the analyte in plasma (Cmax) (time frame: Up to 48 hours after drug administration). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.