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

Phase 1

Completed

• Conditions: Healthy Volunteers; Rheumatoid Arthritis
• Interventions: Drug: fostamatinib; Drug: rifampicin

• Registration Number: NCT01336218
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	fostamatinib	Fostamatinib
2	fostamatinib	Rifampicin
2	rifampicin	Rifampicin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States