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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Bioavailability; Pharmacokinetics

Treatments: Drug: Fostamatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01208155

D4300C00016

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

1

Experimental group

Description:

Fostamatinib 50 mg tablet x 2

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

2

Experimental group

Description:

Fostamatinib 100 mg tablet (batch 1)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

3

Experimental group

Description:

Fostamatinib 100 mg tablet (batch 2)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

4

Experimental group

Description:

Fostamatinib 100 mg tablet (batch 4)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib