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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1356; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183389

1218.28

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Treatment B: BI 1356 and Warfarin

Experimental group

Description:

BI 1356 for 12 days combined with a single dose of warfarin on day 6

Treatment:

Drug: BI 1356

Drug: Warfarin

Treatment A: Warfarin

Active Comparator group

Description:

Warfarin as single dose

Treatment:

Drug: Warfarin