Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

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ClinicalTrials.gov Identifier: NCT01336218

Recruitment Status : Completed

First Posted : April 15, 2011

Last Update Posted : July 22, 2011

Sponsor:

Information provided by:

AstraZeneca

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis Healthy Volunteers	Drug: fostamatinib Drug: rifampicin	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Allocation:	Non-Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin
Study Start Date :	April 2011
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	July 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Rheumatoid arthritis

Drug Information available for: Rifampin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Fostamatinib	Drug: fostamatinib oral tablets, 150mg (3 X 50mg) single dose per period
Experimental: 2 Rifampicin	Drug: fostamatinib oral tablets, 150mg (3 X 50mg) single dose per period Drug: rifampicin oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Outcome Measures

Primary Outcome Measures :

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ]

Secondary Outcome Measures :

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ]
To examine the safety and tolerability of fostamatinib in combination with rifampicin. [ Time Frame: From screening, Day 1 - Day 25, up to follow up visit ]
Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Males or females aged 18 to 55 years (inclusive)
Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion Criteria:

History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
Any previous treatment with fostamatinib

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336218

Locations

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United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

More Information

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Responsible Party:	Kelli Craven, MD, PI, Quintiles, Overland Park, volunteer recruitment
ClinicalTrials.gov Identifier:	NCT01336218 History of Changes
Other Study ID Numbers:	D4300C00015
First Posted:	April 15, 2011 Key Record Dates
Last Update Posted:	July 22, 2011
Last Verified:	July 2011

Keywords provided by AstraZeneca:


Phase 1 healthy volunteers Rheumatoid arthritis RA Fostamatinib	Rifampicin drug-drug interaction Pharmacokinetics Amount of Rifampicin in blood

Additional relevant MeSH terms:

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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Rifampin Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents	Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers

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