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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
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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
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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    
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