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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01336218

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Healthy Volunteers	Drug: fostamatinib Drug: rifampicin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Fostamatinib	Drug: fostamatinib oral tablets, 150mg (3 X 50mg) single dose per period
Experimental: 2 Rifampicin	Drug: fostamatinib oral tablets, 150mg (3 X 50mg) single dose per period Drug: rifampicin oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Arm

Intervention/Treatment

Experimental: 1

Fostamatinib

Drug: fostamatinib

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

Experimental: 2

Rifampicin

Drug: fostamatinib

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

Drug: rifampicin

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

Outcome Measures

Primary Outcome Measures

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured [Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose]

Secondary Outcome Measures

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured [Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose]
To examine the safety and tolerability of fostamatinib in combination with rifampicin. [From screening, Day 1 - Day 25, up to follow up visit]
Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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