Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

NCT ID: NCT01336218

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-07-31

Brief Summary

The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects

Conditions

Rheumatoid Arthritis; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

Fostamatinib

Group Type: EXPERIMENTAL

fostamatinib

Intervention Type: DRUG

oral tablets, 150mg (3 X 50mg) single dose per period

2

Rifampicin

Group Type: EXPERIMENTAL

fostamatinib

Intervention Type: DRUG

oral tablets, 150mg (3 X 50mg) single dose per period

rifampicin

Intervention Type: DRUG

oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Interventions

fostamatinib

oral tablets, 150mg (3 X 50mg) single dose per period

Intervention Type: DRUG

rifampicin

oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Males or females aged 18 to 55 years (inclusive)
• Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
• Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion Criteria

• History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
• Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
• Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
• Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
• Any previous treatment with fostamatinib

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Quintiles, Overland Park, volunteer recruitment

Locations

Research Site

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

D4300C00015

Identifier Type: -

Identifier Source: org_study_id