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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01208155
First received: September 22, 2010
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Bioavailability
Pharmacokinetics
Drug: Fostamatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fostamatinib 50 mg tablet x 2
Drug: Fostamatinib
Oral tablets, 50 mg x 2, single dose
Experimental: 2
Fostamatinib 100 mg tablet (batch 1)
Drug: Fostamatinib
Oral tablets, 100 mg Batch 1, single dose
Experimental: 3
Fostamatinib 100 mg tablet (batch 2)
Drug: Fostamatinib
Oral tablets, 100 mg Batch 2, single dose
Experimental: 4
Fostamatinib 100 mg tablet (batch 4)
Drug: Fostamatinib
Oral tablets, 100 mg Batch 3, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208155

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton, MD AstraZeneca
Principal Investigator: Carlos Prendes, MD Quintiles
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01208155     History of Changes
Other Study ID Numbers: D4300C00016
Study First Received: September 22, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
Healthy
pharmacokinetics
Fostamatinib

ClinicalTrials.gov processed this record on July 20, 2014