Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.
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ClinicalTrials.gov Identifier: NCT01336218 |
Recruitment Status :
Completed
First Posted : April 15, 2011
Last Update Posted : July 22, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis Healthy Volunteers | Drug: fostamatinib Drug: rifampicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | April 2011 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

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 |
- 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 ]
- 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 ]
- To examine the safety and tolerability of fostamatinib in combination with rifampicin. [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336218
United States, Kansas | |
Research Site | |
Overland Park, Kansas, United States |
Responsible Party: | Kelli Craven, MD, PI, Quintiles, Overland Park, volunteer recruitment |
ClinicalTrials.gov Identifier: | NCT01336218 |
Other Study ID Numbers: |
D4300C00015 |
First Posted: | April 15, 2011 Key Record Dates |
Last Update Posted: | July 22, 2011 |
Last Verified: | July 2011 |
Phase 1 healthy volunteers Rheumatoid arthritis RA Fostamatinib |
Rifampicin drug-drug interaction Pharmacokinetics Amount of Rifampicin in blood |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Rifampin Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |
Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |