- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183389
Bioavailability of Warfarin After Coadministration With Multiple Doses of BI 1356 Compared to the Bioavailability of Warfarin Alone in Healthy Male Volunteers
July 4, 2014 updated by: Boehringer Ingelheim
Relative Bioavailability of a Single Oral Dose of Warfarin (10 mg qd) After Coadministration With Multiple Oral Doses of BI 1356 (5 mg qd) Compared to the Bioavailability of a Single Oral Dose of Warfarin (10 mg qd) Alone in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)
To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
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 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age ≥ 18 and Age ≤ 50 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- Homozygote wild-type carriers (*1/*1) of cytochrome P 450 (CYP) 2C9
Exclusion Criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Exclusion criteria specific for this study:
- Anemia at screening
- Galactose intolerance
- Lactase deficiency
- Glucose-galactose-malabsorption
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment B: BI 1356 and Warfarin
BI 1356 for 12 days combined with a single dose of warfarin on day 6
|
|
ACTIVE_COMPARATOR: Treatment A: Warfarin
Warfarin as single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration time curve (AUC) of the analyte in plasma at different time points
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Terminal rate constant in plasma (λz)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Terminal half life of the analyte in plasma (t1/2)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Mean residence time of the analyte in the body after p.o. administration (MRTpo)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time Frame: Up to 168 hours after start of study medication
|
Up to 168 hours after start of study medication
|
Number of patients with adverse events
Time Frame: Up 42 days
|
Up 42 days
|
Number of patients with relevant changes in physical examination
Time Frame: Up to 14 days after last study drug administration
|
Up to 14 days after last study drug administration
|
Number of patients with relevant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Time Frame: Up to 14 days after last study drug administration
|
Up to 14 days after last study drug administration
|
Number of patients with relevant changes in 12-lead resting electrocardiogram (ECG)
Time Frame: Up to 14 days after last study drug administration
|
Up to 14 days after last study drug administration
|
Number of patients with relevant changes in laboratory values
Time Frame: Up to 14 days after last study drug administration
|
Up to 14 days after last study drug administration
|
Assessment of tolerability a 4-point scale by the investigator
Time Frame: Up 42 days
|
Up 42 days
|
International normalised ratio, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (INR AUC0-168)
Time Frame: Up to 168 hours after start of treatment
|
Up to 168 hours after start of treatment
|
International normalised ratio, maximum concentration of the analyte in plasma (INRmax)
Time Frame: Up to 168 hours after start of treatment
|
Up to 168 hours after start of treatment
|
Prothrombin time, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (PT AUC0-168)
Time Frame: Up to 168 hours after start of treatment
|
Up to 168 hours after start of treatment
|
Prothrombin time, maximum concentration of the analyte in plasma (PTmax)
Time Frame: Up to 168 hours after start of treatment
|
Up to 168 hours after start of treatment
|
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
May 1, 2008
Primary Completion (ACTUAL)
October 1, 2008
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (ESTIMATE)
July 8, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1218.28
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Warfarin
-
University Hospital, BrestCompleted
-
University of PadovaCompleted
-
University Hospital, BrestCompletedRecurrent Venous Thromboembolism | Idiopathic Deep Vein ThrombosisFrance
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); Duke Clinical Research InstituteTerminatedIdiopathic Pulmonary FibrosisUnited States
-
Azienda Ospedaliera Universitaria PoliclinicoCompletedDeep Vein ThrombosisItaly
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAtrial FibrillationBrazil
-
National University Hospital, SingaporeUnknownIndications for Warfarin TherapySingapore, Malaysia
-
University of KarachiAdvanced Education & Research Center; Karachi Institute of Heart DiseasesRecruitingLeft Atrial Appendage Aneurysm | Mitral StenosisPakistan
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Cerebrovascular Disorders | Atrial Fibrillation | Arrhythmia | Cerebrovascular Accident | Thrombophlebitis | Cerebral Embolism and Thrombosis