NCT01311622CompletedPhase 1
An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax
Study Overview
Brief Summary
The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures (including genotyping screening sample for CYP2C9 and VKORC1).
- •Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
- •Subjects must be negative for occult blood (stool card) prior to administration.
- •Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive
Exclusion Criteria
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
- •Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
- •A protein C and/or protein S deficiency.
- •Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
- •Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).
Arms & Interventions
warfarin
Experimental
Intervention: warfarin (Drug)
warfarin and fostamatinib
Experimental
Intervention: warfarin (Drug)
warfarin and fostamatinib
Experimental
Intervention: fostamatinib (Drug)
Outcomes
Primary Outcomes
To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax
Time Frame: From pre-dose to 168 h post dose relative to each single warfarin dose
* Pharmacokinetics of warfarin measured by AUC * Pharmacokinetics of warfarin measured Cmax
Secondary Outcomes
- To measure International Normalised Ratio (INR) following administration of warfarin(From pre-dose to 168 h post dose relative to each single warfarin dose)
- To assess the steady-state pharmacokinetics of R406 (active metabolite of fostamatinib) by measuring AUCss, Cmax,ss, tmax,ss and CL/F(From predose on Day 11 until 12 h post dose on Day 14 relative to fostamatinib dosing)
- Safety and tolerability will be measured with regard to adverse events, laboratory assessments, vital signs, physical examination, and 12-lead ECG will be recorded.(From screening, Day -1 to Day 21 and follow up visit (Day 28))
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)Warm Antibody Autoimmune Hemolytic AnemiaNCT02612558Rigel Pharmaceuticals26
Completed
Phase 1
Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy SubjectsHealthy VolunteersPharmacokineticsPioglitazoneDrug-drug InteractionAmount of Pioglitazone in BloodRheumatoid ArthritisNCT01309854AstraZeneca15
Completed
Phase 1
A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) FunctionHepatic ImpairmentHealthy VolunteersPharmacokineticsAmount of R406 in BloodNCT01222455AstraZeneca32
Completed
Phase 2
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) NephropathyIGA NephropathyNCT02112838Rigel Pharmaceuticals76
Completed
Phase 3
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)Immune Thrombocytopenic PurpuraNCT02076412Rigel Pharmaceuticals74