An open-label, randomized 2-period crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of warfarin in combination with oseltamivir in volunteers stabilized on warfarin therapy.

• Conditions: Drug interaction study to investigate the the PD, PK, safety and tolerability of warfarin in combination with oseltamivir in volunteers stabilized on warfarin therapy.

• Registration Number: EUCTR2007-005037-11-GB
• Lead Sponsor: F.Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female subjects, 18-85 years of age, inclusive.
2. Subjects must have been receiving warfarin once daily for at least 4 weeks prior
to screening.
3. Subjects must have regular INR monitoring during warfarin therapy prior to study
entry, and willing to be trained in the use of CoaguChek® devices.
4. INR must fall within a target range of 2.0-3.5 (as determined by
CoaguChek® or a clinical laboratory INR test).
5. A BMI between 18-32 kg/m2 inclusive
6. Able to participate, and willing to give written informed consent and to comply
with the study restrictions
7. Confirmation by dietician questionnaire of a reasonably balanced diet

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. An INR value between screening and Day -1 lower than 2.0 or greater than 3.5.
2. A change in their prescribed daily warfarin dose between screening and Day -1.
3. History of any coagulopathy for example von Willebrand’s disease.
4. Consumption of health products or supplements containing Vitamin K.
5. If capable of reproduction, unwilling to use an effective (barrier) form of
contraception (post-menopausal status must be verified by negative hormone
panel).
6. Positive pregnancy test at screening or Day -1 and lactating women.
7. Confirmed positive urine and/or blood test for drugs of abuse at screening or
Day -1.
8. History of drug or alcohol abuse.
9. Donation or loss of blood over 500 mL within three months prior to screening.
10. Participation in an investigational drug or device study within three months prior
to screening.
11. Smokers of >5 cigarettes or equivalent in tobacco per day (>3 pipefulls or
>3 cigars per day).
12. Use of any prescription drug, over the counter medication or herbal product,
known to be an inducer or inhibitor of CYP450 enzymes or any drugs included in
the list of prohibited medications, taken within 7 days of first dose of study drug,
or 5 times the elimination half-life of the medication, whichever is longer, unless
the patient/volunteer is stable on the stated medication and it has been taken
for a period of = 3 months.
13. Consistent supine systolic blood pressure (SBP) greater than 160 or less than 80
and diastolic blood pressure (DBP) greater than 90 or less than 60 mm Hg
between screening and Day -1.
14. Consistent supine heart rate (HR) at rest greater than 90 less than 45 beats per
minute (bpm) between screening and Day -1.
15. Any clinically significant abnormalities in laboratory test results in this patient
population (including hepatic and renal panels, complete blood count, chemistry
panel, serology and urinalysis) at screening or Day -1.
16. A history of acute clinically significant gastro-intestinal, musculoskeletal,
endocrine, hematological, psychiatric, renal, hepatic, bronchopulmonary,
neurological disease, acute venous thromboembolism within the last 3 months, a
mechanical heart valve, acute stroke, transient ischaemic event (TIA) or acute
myocardial infarction.
17. Creatinine Clearance of <60 mL/min (as estimated using Cockroft-Gault formula).
This may be confirmed by urine creatinine clearance, the results of which will
override the Cockroft-Gault estimated results.
18. Any other concomitant disease or condition that could interfere with, or for which
the treatment of might interfere with, the conduct of the study, or that would, in
the opinion of the investigator, pose an unacceptable risk to the subject in this
study.
19. Known history of clinically significant allergic hypersensitivity reactions or drug
hypersensitivity (non-active hay fever is acceptable), including a known allergy
to the study drug or to any of its components.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified