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
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 April 14, 2014