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Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects

NCT ID: NCT01355354

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to investigate the drug interaction between fostamatinib and digoxin by comparing the safety, tolerability and plasma concentration of digoxin when administered alone and with fostamatinib in healthy subjects.

Detailed Description

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Conditions

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Healthy Volunteers Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Digoxin

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15

2

Fostamatinib

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15

Fostamatinib

Intervention Type DRUG

oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15

Interventions

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Digoxin

oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15

Intervention Type DRUG

Fostamatinib

oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Male or female subjects aged 18 to 45 years (inclusive)
* Minimum weight of 50 kg and body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
* Female subjects must have a negative pregnancy test at screening and on Day -1,must not be lactating, and must be of non-childbearing potential

Exclusion Criteria

* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Absolute neutrophil count of \<2500/mm3 or 2.5 x 109/L
* Previous treatment with fostamatinib or digoxin in the present study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Martin P, Gillen M, Millson D, Oliver S, Brealey C, Elsby R, Baluom M, Lau D, Mant T. Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2811-22. doi: 10.1016/j.clinthera.2015.09.018. Epub 2015 Oct 26.

Reference Type DERIVED
PMID: 26514315 (View on PubMed)

Other Identifiers

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D4300C00026

Identifier Type: -

Identifier Source: org_study_id