NCT01309854

Brief Summary

The purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.

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
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 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

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

2 months

First QC Date

February 21, 2011

Last Update Submit

July 6, 2011

Conditions

Rheumatoid ArthritisHealthy VolunteersPharmacokineticsPioglitazoneDrug-drug InteractionAmount of Pioglitazone in Blood

Keywords

Phase 1healthy volunteerspharmacokineticsRheumatoid arthritisRAfostamatinibpioglitazonedrug-drug interaction

Outcome Measures

Primary Outcomes (2)

  • To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax

    Period 1: Pre-dose to 48h post dose

  • To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax

    Period 2: Pre-dose to 48h post dose

Secondary Outcomes (3)

  • To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax

    Period 1: Pre-dose to 48h post dose

  • To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax

    Period 2: Pre-dose to 48h post dose

  • To examine the safety and tolerability

    From screening, Day -1 to Day 9 and follow up visit (Day 16)

Study Arms (2)

pioglitazone

EXPERIMENTAL
Drug: fostamatinibDrug: pioglitazone

pioglitazone and fostamatinib

EXPERIMENTAL
Drug: pioglitazone

Interventions

fostamatinibDRUG

oral tablets, 100mg (2 X 50mg) twice daily for 8 days

pioglitazone
pioglitazoneDRUG

oral tablets, 30mg single dose per period

pioglitazonepioglitazone 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
  • Males or females (of non-child bearing potential) aged 18 to 55 years (inclusive)
  • Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
  • Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product

You may not qualify if:

  • History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
  • 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 or pioglitazone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinibPioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mark Layton, MD, MRCP

    AstraZeneca

    STUDY DIRECTOR

  • Carlos Prendes, MD

    Quintiles Overland Park, Phase 1 Unit

    PRINCIPAL INVESTIGATOR

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

February 21, 2011

First Posted

March 7, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

US(1)