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

Phase 1CompletedNCT01208155

AstraZeneca24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bioavailability Pharmacokinetics

Interventions

FostamatinibDRUG

Oral tablets, 50 mg x 2, single dose

FostamatinibDRUG

Oral tablets, 100 mg Batch 1, single dose

FostamatinibDRUG

Oral tablets, 100 mg Batch 2, single dose

Fostamatinib

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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

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

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

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

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

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

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 )

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes