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A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)

NCT ID: NCT02780622

Last Updated: 2016-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-07-31

Brief Summary

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This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and warfarin followed by warfarin. The treatment periods will be separated by a washout period of at least 4 days. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

Detailed Description

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Conditions

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Drug Therapy, Combination

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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First Warfarin Then Warfarin and Oseltamivir

Participants will receive warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attend a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

Group Type EXPERIMENTAL

Oseltamivir

Intervention Type DRUG

Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.

Warfarin

Intervention Type DRUG

Warfarin once daily, at a dose determined through titration by participants' usual hematologist.

First Warfarin and Oseltamivir Then Warfarin

Participants will receive oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive warfarin (on Days 1-5) in Treatment Period 2, and attend a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

Group Type EXPERIMENTAL

Oseltamivir

Intervention Type DRUG

Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.

Warfarin

Intervention Type DRUG

Warfarin once daily, at a dose determined through titration by participants' usual hematologist.

Interventions

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Oseltamivir

Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.

Intervention Type DRUG

Warfarin

Warfarin once daily, at a dose determined through titration by participants' usual hematologist.

Intervention Type DRUG

Other Intervention Names

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Tamiflu®

Eligibility Criteria

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Inclusion Criteria

* Participants must have been receiving warfarin once daily for at least 4 weeks prior to Screening
* Participants must have regular International Normalized ratio (INR) monitoring during warfarin therapy prior to study entry, and be willing to be trained in the use of CoaguCheck devices
* INR must fall within a target range of 2.0-3.5
* Body mass index (BMI) between 18-32 kg/m\^2 inclusive

Exclusion Criteria

* An INR value between screening and Day -1 lower than 2.0 or greater than 3.5
* A change in prescribed daily warfarin dose between Screening and Day -1
* History of any coagulopathy
* Consumption of health products or supplements containing vitamin K
* Pregnant or lactating women
* Confirmed positive urine and/or blood test for drugs of abuse at Screening or Day -1
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Surrey, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2007-005037-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP21272

Identifier Type: -

Identifier Source: org_study_id