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Completed

NCT Number: NCT01208155

Study in Healthy Males to Assess 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

Bioavailability Pharmacokinetics

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

  • Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
  • Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)

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 (except for cholecystectomy)
  • 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

Treatment and study plan

Fostamatinib

Drug

Oral tablets, 50 mg x 2, single dose

Primary outcomes

  1. Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period

  2. Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 2 until 96 hours post dose of each treatment period

  3. Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 3 until 96 hours post dose of each treatment period

  4. Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period

  5. Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 1 until 96 hours post dose of each treatment period

  6. Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 2 until 96 hours post dose of each treatment period

  7. Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 3 until 96 hours post dose of each treatment period

  8. Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )

    Time frame: Daily during Treatment Period 4 until 96 hours post dose of each treatment period

Secondary outcomes

  1. To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.

    Time frame: Screening, throughout the 4 treatment periods, and follow-up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2010
Registry last updated
Dec 8, 2010

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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