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Completed

NCT Number: NCT01387308

Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets

Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent prior to any study specific procedures
  • Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, 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 investigational product
  • Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Treatment and study plan

Fostamatinib

Drug

Oral tablets, 50 mg x 2, single dose

Primary outcomes

  1. To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)

    Time frame: From Pre-dose until 96 hours post dose of each treatment period

    Assessments will include but is not limited to: plasma R406 AUC, Cmax

  2. To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)

    Time frame: From pre-dose until 96 hours post dose of each treatment period

    Assessments will include but is not limited to: plasma R406 AUC, Cmax )

Secondary outcomes

  1. To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches

    Time frame: From pre-dose until 96 hours post dose of each treatment period

    The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.

  2. To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.

    Time frame: From pre-dose until 96 hours post dose of each treatment period

    Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 4, 2011
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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