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Bioavailability of Warfarin After Coadministration With Multiple Doses of BI 1356 Compared to the Bioavailability of Warfarin Alone in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02183389
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin

Condition or disease Intervention/treatment Phase
Healthy Drug: Warfarin Drug: BI 1356 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2008
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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
Drug: Warfarin
Drug: BI 1356
Active Comparator: Treatment A: Warfarin
Warfarin as single dose
Drug: Warfarin



Primary Outcome Measures :
  1. 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 ]
  2. Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: Up to 168 hours after start of study medication ]

Secondary Outcome Measures :
  1. 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 ]
  2. Time from dosing to the maximum concentration of the analyte in plasma (tmax) [ Time Frame: Up to 168 hours after start of study medication ]
  3. Terminal rate constant in plasma (λz) [ Time Frame: Up to 168 hours after start of study medication ]
  4. Terminal half life of the analyte in plasma (t1/2) [ Time Frame: Up to 168 hours after start of study medication ]
  5. 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 ]
  6. Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) [ Time Frame: Up to 168 hours after start of study medication ]
  7. 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 ]
  8. Number of patients with adverse events [ Time Frame: Up 42 days ]
  9. Number of patients with relevant changes in physical examination [ Time Frame: Up to 14 days after last study drug administration ]
  10. 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 ]
  11. Number of patients with relevant changes in 12-lead resting electrocardiogram (ECG) [ Time Frame: Up to 14 days after last study drug administration ]
  12. Number of patients with relevant changes in laboratory values [ Time Frame: Up to 14 days after last study drug administration ]
  13. Assessment of tolerability a 4-point scale by the investigator [ Time Frame: Up 42 days ]
  14. 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 ]
  15. International normalised ratio, maximum concentration of the analyte in plasma (INRmax) [ Time Frame: Up to 168 hours after start of treatment ]
  16. 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 ]
  17. Prothrombin time, maximum concentration of the analyte in plasma (PTmax) [ Time Frame: Up to 168 hours after start of treatment ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183389     History of Changes
Other Study ID Numbers: 1218.28
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Warfarin
Linagliptin
Anticoagulants
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action