Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets - Full Text View

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 June 17, 2013