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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fostamatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01387308

D4300C00018

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent prior to any study specific procedures
• Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
• Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them

Exclusion criteria

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
• Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
• Any clinically significant abnormalities in clinical chemistry, haematology 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 5 patient groups

A

Experimental group

Description:

Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

B

Sham Comparator group

Description:

Fostamatinib 50 mg tablet x 3 (Phase 3 batch)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

C

Experimental group

Description:

Fostamatinib 100 mg tablet (new formulation)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

D

Experimental group

Description:

Fostamatinib 150 mg tablet (new formulation)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

E

Experimental group

Description:

Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Treatment:

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib

Drug: Fostamatinib