NCT01311622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

February 21, 2011

Last Update Submit

January 30, 2013

Conditions

Rheumatoid ArthritisHealthy Subjects

Keywords

drug-drug interactionPhase 1healthy subjectswarfarinRheumatoid arthritisRAfostamatinib open-labelpharmacokineticspharmacodynamicslevel of Warfarin in the blood

Outcome Measures

Primary Outcomes (1)

  • To determine PK parameters of R- and S-warfarin including but not limited to AUC and Cmax

    * Pharmacokinetics of warfarin measured by AUC * Pharmacokinetics of warfarin measured Cmax

    From pre-dose to 168 h post dose relative to each single warfarin dose

Secondary Outcomes (3)

  • 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)

Study Arms (2)

warfarin

EXPERIMENTAL
Drug: warfarin

warfarin and fostamatinib

EXPERIMENTAL
Drug: warfarinDrug: fostamatinib

Interventions

warfarinDRUG

2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart

Also known as: Marevan
warfarinwarfarin and fostamatinib
fostamatinibDRUG

2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days

warfarin and fostamatinib

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Warfarinfostamatinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • James Ritter, BM BCh MRCP FRCP

    Quintiles, Phase 1 Unit, London

    PRINCIPAL INVESTIGATOR

  • Mark Layton, MD MRCP (UK)

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

March 9, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

GB(1)