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

NCT01336218 | Completed Phase 1

• 1 other identifier: D4300C00015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Phase 1; healthy volunteers; Rheumatoid arthritis; RA; Fostamatinib; Rifampicin; drug-drug interaction; Pharmacokinetics; Amount of Rifampicin in blood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Fostamatinib

Drug: fostamatinib

2

EXPERIMENTAL

Rifampicin

Drug: fostamatinib; Drug: rifampicin

Interventions

fostamatinib DRUG

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

1; 2

rifampicin DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib; Rifampin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 15, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

US (1)