Back to resultsEffects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
Primary Purpose
Rheumatoid Arthritis, Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fostamatinib
rifampicin
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Phase 1, healthy volunteers, Rheumatoid arthritis, RA, Fostamatinib, Rifampicin, drug-drug interaction, Pharmacokinetics, Amount of Rifampicin in blood
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Fostamatinib
Rifampicin
Outcomes
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
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
To examine the safety and tolerability of fostamatinib in combination with rifampicin.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01336218
Brief Title
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Healthy Volunteers
Keywords
Phase 1, healthy volunteers, Rheumatoid arthritis, RA, Fostamatinib, Rifampicin, drug-drug interaction, Pharmacokinetics, Amount of Rifampicin in blood
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Fostamatinib
Arm Title
2
Arm Type
Experimental
Arm Description
Rifampicin
Intervention Type
Drug
Intervention Name(s)
fostamatinib
Intervention Description
oral tablets, 150mg (3 X 50mg) single dose per period
Intervention Type
Drug
Intervention Name(s)
rifampicin
Intervention Description
oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
Primary Outcome Measure Information:
Title
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
Time Frame
Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
Secondary Outcome Measure Information:
Title
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
Time Frame
Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose
Title
To examine the safety and tolerability of fostamatinib in combination with rifampicin.
Description
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.
Time Frame
From screening, Day 1 - Day 25, up to follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
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