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Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598571
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):

Brief Summary:
Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.

Condition or disease Intervention/treatment Phase
Healthy Drug: Fostamatinib Phase 1

Detailed Description:
A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib With Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: Fostamatinib 50 mg tablet Drug: Fostamatinib
Fostamatinib 50 mg tablet

Experimental: Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose Drug: Fostamatinib
Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose

Primary Outcome Measures :
  1. The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib. [ Time Frame: Up to 96 hours post dose ]
  2. Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz. [ Time Frame: Up to 96 hours post dose ]
    AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase

  3. Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406. [ Time Frame: 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose ]
    PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT

Secondary Outcome Measures :
  1. Number of participants with Adverse Events. [ Time Frame: Up to Day 12 ]
  2. Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings. [ Time Frame: Up to Day 12 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
  • Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
  • Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
  • Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator

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 identifier (NCT number): NCT01598571

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United Kingdom
Ruddington, Nottingham, United Kingdom
Sponsors and Collaborators
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Study Director: Mark Layton, MD AstraZeneca, Alderley Park
Principal Investigator: Sharan Sidhu, MB CHB, BAO, MRCS Quotient Clinical Unit

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Responsible Party: AstraZeneca Identifier: NCT01598571    
Other Study ID Numbers: D4300C00027
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012
Keywords provided by AstraZeneca:
Phase 1
Healthy male volunteers
R406 plasma AUC and Cmax
R406 plasma AUC0-t