Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Fostamatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01598571

D4300C00027

QBR112696

Details and patient eligibility

About

Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.

Full description

A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.

Enrollment

37 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product

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
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