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

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Bioavailability
• Intervention / Treatment: Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Fostamatinib 50 mg tablet x 2	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 1, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 3, single dose
Experimental: 2; Fostamatinib 100 mg tablet (batch 1)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 1, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 3, single dose
Experimental: 3; Fostamatinib 100 mg tablet (batch 2)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 1, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 3, single dose
Experimental: 4; Fostamatinib 100 mg tablet (batch 4)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 1, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 2, single dose; Drug: Fostamatinib; Oral tablets, 100 mg Batch 3, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 )	Daily during Treatment Period 1 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 2 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 3 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 4 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 1 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 2 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 3 until 96 hours post dose of each treatment period
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 )	Daily during Treatment Period 4 until 96 hours post dose of each treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Screening, throughout the 4 treatment periods, and follow-up

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Mark Layton, MD, AstraZeneca; Principal Investigator: Carlos Prendes, MD, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 22, 2010
• First Submitted That Met QC Criteria: September 22, 2010
• First Posted (Estimate): September 23, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2010
• Last Update Submitted That Met QC Criteria: December 7, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Healthy; pharmacokinetics; Phase 1; Fostamatinib
• Other Study ID Numbers: D4300C00016